Identity
- Trade Name
- Preat Implant Prosthetics FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Astra®-compatible Aqua 3.5/4.0mm Titanium Scan Body Kit Contains: 1 Astra®-compatible Aqua 3.5/4.0mm Titanium Scan Body 1 Astra®-compatible Aqua 3.5/4.0 mm Titanium Screw FDA UDI
- Model / Reference
- 9002145 FDA UDI
- Description
- Astra®-compatible Aqua 3.5/4.0mm Titanium Scan Body Kit Contains: 1 Astra®-compatible Aqua 3.5/4.0mm Titanium Scan Body 1 Astra®-compatible Aqua 3.5/4.0 mm Titanium Screw FDA UDI
Identifiers
- Catalog Number
- 9002145 FDA UDI
- Primary DI / UDI-DI
- 00842092179536 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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
Category: Dental implant abutment analog, intraoral-scanning, single-use
Preat Implant Prosthetics by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment analog, intraoral-scanning, single-use.
- SET ZZ BASE NB-Z-WSM B4.1 — Zirkonzahn GmbH · Class I
- DIO Zimmer Scan Adapter — DIO Corporation · Class I
- Zirlux — HENRY SCHEIN, INC. · Class I
- TruScan body — Truabutment Korea Co., Ltd · Class I
- DIRECTscan™ Adapter Single Wing-A — APOLLO IMPLANT COMPONENTS SP Z O O · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- SET ZZ BASE C-J-WSM 4.3 — Zirkonzahn GmbH · Class I
- SET ZZ BASE F-DX-WSM 3.8 — Zirkonzahn GmbH · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI 0e2729e6-be13-4024-9d3c-dbadb9160163 35 fields · synced May 31, 2026