Identity
- Trade Name
- Mizzy Millennium FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Denture Acrylic QC Deep Veined 1 lb P& L FDA UDI
- Model / Reference
- 6010039 FDA UDI
- Description
- Denture Acrylic QC Deep Veined 1 lb P& L FDA UDI
Identifiers
- Catalog Number
- 6010039 FDA UDI
- Primary DI / UDI-DI
- H66860100391 FDA UDI
- 510(k) Number
- K983876 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture repair kit, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture repair kit, professional
Mizzy Millennium by Keystone Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture repair kit, professional.
- Bosworth TruRepair — Harry J. Bosworth Co. · Class II
- HYGITECH — HYGITECH · Class I
- Beesure — ASCEND EAGLE INCORPORATED · Class I
- HYGITECH — HYGITECH · Class I
- Bosworth TruRepair — Harry J. Bosworth Co. · Class II
- Bosworth Duz-All — Harry J. Bosworth Co. · Class II
- HYGITECH — HYGITECH · Class I
- Bosworth TruRepair — Harry J. Bosworth Co. · Class II
Cleared under the same submission
K983876 also covers:
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
- Mizzy Millennium — Keystone Industries
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keystone Industries
Sources (1)
- FDA UDI 3c07fdce-46bb-4ccd-bae7-fab1d6938cd2 37 fields · synced Jun 9, 2026