FDA UDI
In Commercial Distribution
🇺🇸 United States
ProSoft Professional Denture Reliner
DI: 00852305002018
·
Model: 2ps
·
PERMA LABORATORIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProSoft Professional Denture Reliner
- Primary DI
- 00852305002018
- Version / Model
- 2ps
- Company Name
- PERMA LABORATORIES LLC
- Labeler DUNS
- 111780698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-14
- Public Version
- 3
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 698f4e6c-43b2-4bf0-a337-f1bda560f0ad
Device Description
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBP | Reliner, Denture, Over The Counter | Dental | 872.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31788 | Denture reliner, soft, home-use | A denture relining material such as plastic resin intended to be self-applied at home as a permanent coating or lining on the base or tissue-contact surface of a denture for improved fitting, and which sets to a soft, plastic state. It will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852305002018 | GS1 |
Customer Contacts
- Phone
- 1-800-988-9194
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121318 | 000 |