| Primary Device ID | 00852305002070 |
| NIH Device Record Key | 9bbde7b5-7997-4443-8a05-529eb215d19b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perma Soft Denture Reliner |
| Version Model Number | 4c |
| Company DUNS | 111780698 |
| Company Name | PERMA LABORATORIES LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com | |
| Phone | 1-800-988-9194 |
| permalabs@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852305002070 [Primary] |
| EBP | Reliner, Denture, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-08-09 |
| Device Publish Date | 2018-06-14 |
| 00852305002018 - ProSoft Professional Denture Reliner | 2018-08-09 A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the b |
| 00852305002070 - Perma Soft Denture Reliner | 2018-08-09A 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. |
| 00852305002070 - Perma Soft Denture Reliner | 2018-08-09 A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the b |
| 00852305002117 - PERK Emergency Denture Repair Kit | 2018-07-16 A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It |