Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

i-system Sinus Abutment — Class IIb MDD by Novodent SA

MD Atlas
Novodent SA

EUDAMED last updated this device on Sep 15, 2025

i-system Sinus Abutment

B-07640168186708

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Novodent SA
UDI-DI code: 07640168186708
Reference / catalog number: I-SSINA5065(3)

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Novodent SA
SRN: CH-MF-000023309
Manufacturer status: Active

Related devices

Abutment Handle763018820003BXOn the market Abutment Handle763018820003BXOn the market Abutment Impression Coping Pick Up764016818003D7On the market Abutment Impression Coping Pick Up764016818003D7On the market Abutment Impression Coping Pick Up Guide Pin764016818003D7On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Türkiye; available across 2 countries total.

Country	On market since	Until
TürkiyePrimary placement	Jan 29, 2021	Still on market
Italy	Jun 1, 2021	Still on market

Device identification

Trade name: i-system Sinus Abutment
UDI-DI code: 07640168186708
Basic UDI-DI: B-07640168186708
Reference / catalog number: I-SSINA5065(3)
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: i-system Sinus Abutment
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P01020180DENTAL IMPLANTS - ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification