Identity
- Trade Name
- JUSTI DENTURE FDA UDI
- Generic Name
- Denture reliner, soft, home-use FDA UDI
- Device Name
- JUSTI DENTURE RELINER KIT SOFT FDA UDI
- Model / Reference
- 072-14-0002 FDA UDI
- Description
- JUSTI DENTURE RELINER KIT SOFT FDA UDI
Identifiers
- Primary DI / UDI-DI
- D772ATI1400020 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Denture reliner, soft, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Yes
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
Category: Denture reliner, soft, home-use
Justi Denture by American Tooth Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, soft, home-use.
- DenSureFit — OTC DENTAL · Class II
- DenSureFit Pro — OTC DENTAL · Class II
- Perma Soft Denture Reliner — PERMA LABORATORIES · Class II
- ProSoft Professional Denture Reliner — PERMA LABORATORIES · Class II
- Reline-it — Doc Brands, Inc. · Class II
- Reline-It — Majestic Drug Co., Inc. · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
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 |
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Manufacturer
- Manufacturer
- American Tooth Industries
Sources (1)
- FDA UDI 81791709-a0f0-4984-ad85-e99e235f8957 33 fields · synced Jun 8, 2026