Data from EUDAMED, last updated Jul 30, 2026

Impression Material

76303929ASIL190613K

40 references

Class IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk category: Class IIa
Manufacturer: Dent4You AG

Device family identification

Device name: —
: 76303929ASIL190613K
Device model: Impression Material
: GS1
Version date: Mar 18, 2026

Classification

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk category: Class IIa
Status: On the market

Device characteristics

No device characteristics flagged

References by status

Manufacturer & authorised representative

Manufacturer

Name: Dent4You AG
: CH-MF-000028926
Country: Switzerland
Email: info.ch@coltene.com
Phone: +41717575300

Authorised representative

Name: Dent4you GmbH
: DE-AR-000006093
Country: Germany
Phone: +49 7345 236540

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
AFFINIS fast heavy body 2 x 75ml	AFFINIS fast heavy body 2 x 75ml	`6620`	`07630243635290`	2	On the market
AFFINIS fast heavy body Refill 20 x 75ml	AFFINIS fast heavy body Refill 20 x 75ml	`6685`	`07630243635306`	20	On the market
AFFINIS fast light body 2 x 50ml	AFFINIS fast light body 2 x 50ml	`6601`	`07630243635139`	2	On the market
AFFINIS fast light body Refill 20 x 50ml	AFFINIS fast light body Refill 20 x 50ml	`6680`	`07630243635146`	20	On the market
AFFINIS fast putty soft	AFFINIS fast putty soft	`6531`	`07630243635375`	2	On the market
AFFINIS fast regular body 2 x 50 ml	AFFINIS fast regular body 2 x 50 ml	`6611`	`07630243635177`	2	On the market
AFFINIS fast regular body Refill 20 x 50 ml	AFFINIS fast regular body Refill 20 x 50 ml	`6682`	`07630243635184`	20	On the market
AFFINIS heavy body 2 x 75ml	AFFINIS heavy body 2 x 75ml	`6520`	`07630243635276`	2	On the market
AFFINIS heavy body BLACK EDITION 2 x 75 ml	AFFINIS heavy body BLACK EDITION 2 x 75 ml	`60019554`	`07630243635313`	2	On the market
AFFINIS heavy body BLACK EDITION System 360 Refill, 2 x 380 ml	AFFINIS heavy body BLACK EDITION System 360 Refill, 2 x 380 ml	`60019776`	`07630243635320`	2	On the market
AFFINIS heavy body Refill 20 x 75ml	AFFINIS heavy body Refill 20 x 75ml	`6585`	`07630243635283`	20	On the market
AFFINIS heavy body System 360 Starter Kit, 1 x 380ml	AFFINIS heavy body System 360 Starter Kit, 1 x 380ml	`6485`	`07630243635252`	1	On the market
AFFINIS heavy body System 360, 2 x 380ml	AFFINIS heavy body System 360, 2 x 380ml	`6487`	`07630243635269`	2	On the market
AFFINIS light body 2 x 50ml	AFFINIS light body 2 x 50ml	`6501`	`07630243635115`	2	On the market
AFFINIS light body Refill 20 x 50ml	AFFINIS light body Refill 20 x 50ml	`6580`	`07630243635122`	20	On the market
AFFINIS MonoBody 2 x 75ml	AFFINIS MonoBody 2 x 75ml	`6547`	`07630243635238`	2	On the market
AFFINIS MonoBody Refill 20 x 75 ml	AFFINIS MonoBody Refill 20 x 75 ml	`6587`	`07630243635245`	20	On the market
AFFINIS MonoBody System 360, 2 x 380ml	AFFINIS MonoBody System 360, 2 x 380ml	`6482`	`07630243635221`	2	On the market
AFFINIS PRECIOUS light body Refill 2 x 50ml	AFFINIS PRECIOUS light body Refill 2 x 50ml	`6775`	`07630243635191`	2	On the market
AFFINIS PRECIOUS regular body Refill 2 x 50ml	AFFINIS PRECIOUS regular body Refill 2 x 50ml	`6776`	`07630243635207`	2	On the market
AFFINIS PRECIOUS Trial Kit light body 1 x 50ml + regular body 1 x 50ml	AFFINIS PRECIOUS Trial Kit light body 1 x 50ml + regular body 1 x 50ml	`3851`	`07630243635214`	2	On the market
AFFINIS putty soft	AFFINIS putty soft	`6530`	`07630243635351`	2	On the market
AFFINIS putty super soft	AFFINIS putty super soft	`6535`	`07630243635368`	2	On the market
AFFINIS putty System 360 Single Pack, 2 x 380ml	AFFINIS putty System 360 Single Pack, 2 x 380ml	`6472`	`07630243635344`	2	On the market
AFFINIS regular body 2 x 50ml	AFFINIS regular body 2 x 50ml	`6511`	`07630243635153`	2	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
AFFINIS fast heavy body 2 x 75ml	AFFINIS fast heavy body 2 x 75ml	`6620`	`07630243635290`	2	On the market
AFFINIS fast heavy body Refill 20 x 75ml	AFFINIS fast heavy body Refill 20 x 75ml	`6685`	`07630243635306`	20	On the market
AFFINIS fast light body 2 x 50ml	AFFINIS fast light body 2 x 50ml	`6601`	`07630243635139`	2	On the market
AFFINIS fast light body Refill 20 x 50ml	AFFINIS fast light body Refill 20 x 50ml	`6680`	`07630243635146`	20	On the market
AFFINIS fast putty soft	AFFINIS fast putty soft	`6531`	`07630243635375`	2	On the market
AFFINIS fast regular body 2 x 50 ml	AFFINIS fast regular body 2 x 50 ml	`6611`	`07630243635177`	2	On the market
AFFINIS fast regular body Refill 20 x 50 ml	AFFINIS fast regular body Refill 20 x 50 ml	`6682`	`07630243635184`	20	On the market
AFFINIS heavy body 2 x 75ml	AFFINIS heavy body 2 x 75ml	`6520`	`07630243635276`	2	On the market
AFFINIS heavy body BLACK EDITION 2 x 75 ml	AFFINIS heavy body BLACK EDITION 2 x 75 ml	`60019554`	`07630243635313`	2	On the market
AFFINIS heavy body BLACK EDITION System 360 Refill, 2 x 380 ml	AFFINIS heavy body BLACK EDITION System 360 Refill, 2 x 380 ml	`60019776`	`07630243635320`	2	On the market
AFFINIS heavy body Refill 20 x 75ml	AFFINIS heavy body Refill 20 x 75ml	`6585`	`07630243635283`	20	On the market
AFFINIS heavy body System 360 Starter Kit, 1 x 380ml	AFFINIS heavy body System 360 Starter Kit, 1 x 380ml	`6485`	`07630243635252`	1	On the market
AFFINIS heavy body System 360, 2 x 380ml	AFFINIS heavy body System 360, 2 x 380ml	`6487`	`07630243635269`	2	On the market
AFFINIS light body 2 x 50ml	AFFINIS light body 2 x 50ml	`6501`	`07630243635115`	2	On the market
AFFINIS light body Refill 20 x 50ml	AFFINIS light body Refill 20 x 50ml	`6580`	`07630243635122`	20	On the market
AFFINIS MonoBody 2 x 75ml	AFFINIS MonoBody 2 x 75ml	`6547`	`07630243635238`	2	On the market
AFFINIS MonoBody Refill 20 x 75 ml	AFFINIS MonoBody Refill 20 x 75 ml	`6587`	`07630243635245`	20	On the market
AFFINIS MonoBody System 360, 2 x 380ml	AFFINIS MonoBody System 360, 2 x 380ml	`6482`	`07630243635221`	2	On the market
AFFINIS PRECIOUS light body Refill 2 x 50ml	AFFINIS PRECIOUS light body Refill 2 x 50ml	`6775`	`07630243635191`	2	On the market
AFFINIS PRECIOUS regular body Refill 2 x 50ml	AFFINIS PRECIOUS regular body Refill 2 x 50ml	`6776`	`07630243635207`	2	On the market
AFFINIS PRECIOUS Trial Kit light body 1 x 50ml + regular body 1 x 50ml	AFFINIS PRECIOUS Trial Kit light body 1 x 50ml + regular body 1 x 50ml	`3851`	`07630243635214`	2	On the market
AFFINIS putty soft	AFFINIS putty soft	`6530`	`07630243635351`	2	On the market
AFFINIS putty super soft	AFFINIS putty super soft	`6535`	`07630243635368`	2	On the market
AFFINIS putty System 360 Single Pack, 2 x 380ml	AFFINIS putty System 360 Single Pack, 2 x 380ml	`6472`	`07630243635344`	2	On the market
AFFINIS regular body 2 x 50ml	AFFINIS regular body 2 x 50ml	`6511`	`07630243635153`	2	On the market

Impression Material

Device family identification

Classification

Device characteristics

References by status

Manufacturer & authorised representative

Manufacturer

Authorised representative

Device family identification

Classification

Device characteristics

EMDN code(s)

References by status

Manufacturer & authorised representative

Manufacturer

Authorised representative

References

EMDN code(s)

References