Identity
- Trade Name
- Sleeve EUDAMEDSleeve for titanium cementable base FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Sleeve for titanium cem. Base, burn-out EUDAMEDSleeve for titanium cementable base, burn-out d 3.3/3.8/4.3 mm FDA UDI
- Model / Reference
- J2261.4301 EUDAMEDFDA UDI
- Description
- Sleeve for titanium cementable base, burn-out d 3.3/3.8/4.3 mm FDA UDI
Identifiers
- Catalog Number
- J2261.4301 FDA UDI
- Primary DI / UDI-DI
- 04099797004045 EUDAMEDE219J226143011 FDA UDI
- Basic UDI-DI
- 40997970008108000000000QN EUDAMED
- Secondary DI
- E219J226143011 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Sleeve by ALTATEC GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970008108000000000QN | Class I | Active |
| EUDAMED | European Union | CE/MDR | 40997970008108000000000QN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED b85af4f7-313f-46a5-81d8-7c6a3796c830 61 fields · synced May 31, 2026
- FDA UDI 0bc09949-15f5-4dc9-85d8-99a47d5c16cd 35 fields · synced May 29, 2026