Identity
- Trade Name
- Preat Implant Prosthetics FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Multi-Unit Temporary Healing Cap (.050 Hex) Kit Contains: 1 Multi-Unit Temporary Healing Cap 1 Multi-Unit Titanium Screw (.050 Hex) FDA UDI
- Model / Reference
- 9003722 FDA UDI
- Description
- Multi-Unit Temporary Healing Cap (.050 Hex) Kit Contains: 1 Multi-Unit Temporary Healing Cap 1 Multi-Unit Titanium Screw (.050 Hex) FDA UDI
Identifiers
- Catalog Number
- 9003722 FDA UDI
- Primary DI / UDI-DI
- 00842092179772 FDA UDI
- 510(k) Number
- K220823 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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, temporary, preformed, single-use
Preat Implant Prosthetics by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K220823 also covers:
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat 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 11d08894-0e32-4400-b891-f42cc55ea47f 36 fields · synced May 31, 2026