Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Class I - Dental Instruments EUDAMEDAnalog for P64 FDA UDI
- Model / Reference
- D1-P64 EUDAMEDFDA UDI
- Description
- Analog for P64 FDA UDI
Identifiers
- Catalog Number
- D1-P64 FDA UDI
- Primary DI / UDI-DI
- 07290111270390 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011127TOOLSClassI3T EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant analog
Tools by A.b. Dental Devices Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- A.b. Dental Devices Ltd
Sources (2)
- FDA UDI cd8279e8-880b-41bc-be22-67e580528fba 35 fields · synced Jul 14, 2026
- EUDAMED 2e68dac1-1b0e-4d03-9e6e-2333a15f18ca 61 fields · synced Jul 14, 2026