Transfer Impression Coping Guide Pin
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Transfer Impression Coping Guide Pin EUDAMEDFDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
- Device Name
- Transfer Impression Coping Guide Pin EUDAMED
- Model / Reference
- TIGPTRS EUDAMEDFDA UDITIGPTRL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800070217672 EUDAMEDFDA UDI08800070217689 FDA UDI
- Basic UDI-DI
- B-08800070217672 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental prosthesis/implant abutment screw analog, single-use
Transfer Impression Coping Guide Pin by Izenimplant Co., Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Izenimplant Co., Ltd.
Sources (3)
- FDA UDI 7d12b372-92e1-458a-a8db-5774856b97c4 32 fields · synced Jul 30, 2026
- FDA UDI 20515d72-67f3-4298-aaba-9fe0974d20b6 32 fields · synced May 30, 2026
- EUDAMED 94146ec6-8be4-4b9d-9fd2-40ec43034da4 61 fields · synced Jul 30, 2026