Identity
- Trade Name
- Prehma FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Mylar strips (Tube x 1000) FDA UDI
- Model / Reference
- 36-01122 FDA UDI
- Description
- Mylar strips (Tube x 1000) FDA UDI
Identifiers
- Catalog Number
- 36-01122 FDA UDI
- Primary DI / UDI-DI
- H66836011221 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental matrix band, single-use
Prehma by Keystone Industries — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental matrix band, single-use.
- Plasdent — PLASDENT CORP. · Class I
- 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- MEDICOM SAFEMATRIX — AMD Medicom Inc · Class I
- Black Triangle Matrix — Bioclear Matrix Systems, LLC · Class I
- Cure-Thru Clear Cervical Matrices — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Cure-Thru Clear Cervical Matrices — PREMIER DENTAL PRODUCTS COMPANY · Class I
- JMU — JMU DENTAL, INC · 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
- Keystone Industries
Sources (1)
- FDA UDI 942bb679-46a4-43cf-a97c-4cdefaaea8f4 35 fields · synced Jun 9, 2026