Identity
- Trade Name
- O-Ring FDA UDI
- Generic Name
- Dental laboratory mandrel FDA UDI
- Device Name
- Denture Stippling Mandrel FDA UDI
- Model / Reference
- 6000005 FDA UDI
- Description
- Denture Stippling Mandrel FDA UDI
Identifiers
- Catalog Number
- 6000005 FDA UDI
- Primary DI / UDI-DI
- 00842092112212 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Dental laboratory mandrel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 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
No
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 laboratory mandrel
O-Ring by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental laboratory mandrel.
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Pure Buff — Jordco, Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · 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 60c4418c-d395-463b-ba73-86cd89bb7d3a 35 fields · synced May 30, 2026