Identity
- Trade Name
- 3D Dental FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Matrix Bands .0015 12/Pk #1 FDA UDI
- Model / Reference
- MB15-1D FDA UDI
- Description
- Matrix Bands .0015 12/Pk #1 FDA UDI
Identifiers
- Catalog Number
- MB15-1D FDA UDI
- Primary DI / UDI-DI
- 00817169024798 FDA UDI
- FDA Product Code
- KCQ FDA UDI
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6570 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental matrix band, single-use
3D Dental by 3d Dental Designs And Development, Llc — 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
- 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
- Prehma — Keystone Industries · 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
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI f2f07d12-9211-423e-ac93-2f7c0f88f4a2 34 fields · synced May 30, 2026