Identity
- Trade Name
- GL - SINGLE THICKNESS (25) FDA UDI
- Generic Name
- Bite registration rim wax, plate FDA UDI
- Device Name
- Bite Registration Wax EUDAMEDGL - SINGLE THICKNESS (25) FDA UDI
- Model / Reference
- 260-034 EUDAMEDFDA UDI
- Description
- GL - SINGLE THICKNESS (25) FDA UDI
Identifiers
- Catalog Number
- 260-034 FDA UDI
- Primary DI / UDI-DI
- +D7752600341 EUDAMEDD7752600341 FDA UDI
- Basic UDI-DI
- ++D7752600317Z EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q01020203 OCCLUSAL WAXES EUDAMED
- GMDN Term
- Bite registration rim wax, plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Bite Registration Wax by Great Lakes Dental Technologies — 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D7752600317Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes Dental Technologies
- EUDAMED SRN
- US-MF-000003408
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2ee401a5-682c-44e5-92f6-a70e11835fdd 61 fields · synced Jul 18, 2026
- FDA UDI a2a988e5-1762-463a-b04e-aa0bae559886 35 fields · synced May 30, 2026