Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- Dental laboratory mandrel FDA UDI
- Device Name
- K-type Standard Mandrel FDA UDI
- Model / Reference
- PDS-KRRE FDA UDI
- Description
- K-type Standard Mandrel FDA UDI
Identifiers
- Catalog Number
- PDS-KRRE FDA UDI
- Primary DI / UDI-DI
- D832PDSKRRE1 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Dental laboratory mandrel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental laboratory mandrel
Plasdent by Plasdent Corp. — 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
- Preat — PREAT Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- NTI — NTI - Kahla GmbH Rotary Dental Instruments · 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
- Plasdent Corp.
Sources (1)
- FDA UDI e3a3e139-5134-4182-9e41-4f4d901778c0 34 fields · synced May 31, 2026