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

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Organization name
UDI-DI code
Reference / catalog number

Alpha Dent Implants — Class IIb MDR by Alpha Dent Implants GmbH

MD Atlas
Alpha Dent Implants GmbH

EUDAMED last updated this device on May 24, 2026

Alpha Dent Implants

4260687SDSuperiorActive22

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alpha Dent Implants GmbH
UDI-DI code: 04060474008816
Reference / catalog number: ISPA 3.5x10

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View device family (Basic UDI)

Manufacturer information

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

Related devices

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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

Critical warnings

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

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

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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: 04060474008816
Basic UDI-DI: 4260687SDSuperiorActive22
Reference / catalog number: ISPA 3.5x10
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: 3.5 MU50
10 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

P01020101DENTAL IMPLANTS

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

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