Identity
- Trade Name
- Preat Implant Prosthetics FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Multi-Unit Verification Cylinder w/SRA Screw Kit contains: 1 Multi-Unit Verification Cylinder 1 SRA Screw FDA UDI
- Model / Reference
- 9003736 FDA UDI
- Description
- Multi-Unit Verification Cylinder w/SRA Screw Kit contains: 1 Multi-Unit Verification Cylinder 1 SRA Screw FDA UDI
Identifiers
- Catalog Number
- 9003736 FDA UDI
- Primary DI / UDI-DI
- 00842092165386 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
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, temporary, preformed, single-use
The Preat Implant Prosthetics device is a multi-unit verification cylinder with an SRA screw, designed for temporary use in dental implant restorative and laboratory procedures. This single-use prefabricated device provides a temporary intermediate fixture level during the oral soft-tissue healing and sculpturing period before final prosthesis restoration.
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
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI 9c741cff-4748-43e5-818d-52cfe31cd07e 36 fields · synced Jul 25, 2026