Identity
- Trade Name
- Preat FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- ASC NobelActive™/Conical-compatible NP X 9mm Engaging Titanium Base. kit contains . 1 ASC NobelActive™/Conical-compatible NP X 9mm Engaging Titanium Base. 2 ASC NobelActive™/Conical-compatible NP Screws FDA UDI
- Model / Reference
- 9000868 FDA UDI
- Description
- ASC NobelActive™/Conical-compatible NP X 9mm Engaging Titanium Base. kit contains . 1 ASC NobelActive™/Conical-compatible NP X 9mm Engaging Titanium Base. 2 ASC NobelActive™/Conical-compatible NP Screws FDA UDI
Identifiers
- Catalog Number
- 9000868 FDA UDI
- Primary DI / UDI-DI
- 00842092170618 FDA UDI
- 510(k) Number
- K183518 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Preat by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K183518 also covers:
- Clix Ball Implant Abutments — PREAT Corporation
- Clix Ball Implant Abutments — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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 162ef9a1-e145-449b-96bd-ffc1485657bd 36 fields · synced Jun 1, 2026