EUDAMED last updated this device on May 29, 2026

Alpha Dent Implants

4260687SDActiveKonusYJ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alpha Dent Implants GmbH
UDI-DI code: 04060474007635
Reference / catalog number: IAK 6x10

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 29, 2026

Alpha Dent Implants

4260687SDActiveKonusYJ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alpha Dent Implants GmbH
UDI-DI code: 04060474007635
Reference / catalog number: IAK 6x10

View device family (Basic UDI)

Device identification

Trade name: Alpha Dent Implants
UDI-DI code: 04060474007635
Basic UDI-DI: 4260687SDActiveKonusYJ
Reference / catalog number: IAK 6x10
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Titanium endosseous dental implant intended for prosthetic rehabilitation of partially or fully edentulous patients. Sterile single-use device for dental implantation procedures
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10 MU50
6 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04060474007635

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

P01020101DENTAL IMPLANTS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW001
Single-use sterile device. Do not resterilize or reuse

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Nov 21, 2025	Still on market

Device identification

Trade name: Alpha Dent Implants
UDI-DI code: 04060474007635
Basic UDI-DI: 4260687SDActiveKonusYJ
Reference / catalog number: IAK 6x10
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Titanium endosseous dental implant intended for prosthetic rehabilitation of partially or fully edentulous patients. Sterile single-use device for dental implantation procedures
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10 MU50
6 MU50

Manufacturer information

Organization name: Alpha Dent Implants GmbH
SRN: DE-MF-000007046
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04060474007635

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

P01020101DENTAL IMPLANTS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW001
Single-use sterile device. Do not resterilize or reuse

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

Certificates

Certificate health across this manufacturer's portfolio.

26 0085 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Mar 15, 2031
25 0445 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Nov 20, 2030

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Nov 21, 2025	Still on market

Alpha Dent Implants

Alpha Dent Implants

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices