Identity
- Trade Name
- Implant Prosthetics FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Astra®-compatible Aqua 3.5/4.0mm Esthetic Abutment 15° Angle, Anterior FDA UDI
- Model / Reference
- 8002170 FDA UDI
- Description
- Astra®-compatible Aqua 3.5/4.0mm Esthetic Abutment 15° Angle, Anterior FDA UDI
Identifiers
- Catalog Number
- 8002170 FDA UDI
- Primary DI / UDI-DI
- 00842092102459 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
The Implant Prosthetics device is a prefabricated dental implant suprastructure, designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration. It consists of one or more structural components, including abutments, bars, rings, and coping, made from various materials such as titanium, plastic, and gold alloy. The device is used in conjunction with prosthetic devices and can be replaced during cleaning cycles.
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI b388caf5-a5ed-4114-a4b4-a4b8690673a9 35 fields · synced Jun 25, 2026