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PROGRESSIVE-LINE Gingiva punch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5041.3304
by ALTATEC GmbH
Identity
- Trade Name
- PROGRESSIVE-LINE Gingiva punch EUDAMEDGuide Gingiva punch, PL FDA UDI
- Generic Name
- Dental soft-tissue coring punch, reusable FDA UDI
- Device Name
- Guide Gingiva punch, PROGRESSIVE-LINE EUDAMEDGuide Gingiva punch, PL, d 3.3 mm FDA UDI
- Model / Reference
- J5041.3304 EUDAMEDFDA UDI
- Description
- Guide Gingiva punch, PL, d 3.3 mm FDA UDI
Identifiers
- Catalog Number
- J5041.3304 FDA UDI
- Primary DI / UDI-DI
- 04099797994629 EUDAMEDE219J504133041 FDA UDI
- Basic UDI-DI
- 40997970004035000000000JK EUDAMED
- Secondary DI
- E219J504133041 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental soft-tissue coring punch, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 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
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 3.3 Millimeter FDA UDI
PROGRESSIVE-LINE Gingiva punch by ALTATEC GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970004035000000000JK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 14b824f6-9a0b-4aab-81df-1b7a5c08088f 61 fields · synced Jun 18, 2026
- FDA UDI f9ea4a01-1e23-47b6-a95c-e1d32e1251f4 36 fields · synced May 30, 2026