PermaSoft® N812100
GUDID D001N8121000
Contains one (1) 120 gram powder (Clear), two (2) 60 milliliter liquids, and one (1) 30 milliliter sealer
Dentsply International Inc.
Dental appliance fabrication material, resin| Primary Device ID | D001N8121000 |
| NIH Device Record Key | a3bb8d6e-7d90-4512-a18b-1e76169da339 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PermaSoft® |
| Version Model Number | Soft Denture Liner 120 G Kit Clear |
| Catalog Number | N812100 |
| Company DUNS | 606173334 |
| Company Name | Dentsply International Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D001N8121000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K933468
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-11-10 |
| Device Publish Date | 2017-01-31 |
On-Brand Devices [PermaSoft®]
| D001N8160050 | Sealer |
| D001N8160020 | Sealer |
| D001N8151050 | Powder Clear |
| D001N8151030 | Powder Clear |
| D001N8151020 | Powder Clear |
| D001N8151010 | Powder Clear |
| D001N8150050 | Powder Pink |
| D001N8150030 | Powder Pink |
| D001N8150020 | Powder Pink |
| D001N8140050 | Liquid |
| D001N8140020 | Liquid |
| D001N8125000 | Contains one (1) 500 gram powder (Pink), one (1) 500 milliliter liquid, and one (1) 105 millilit |
| D001N8121000 | Contains one (1) 120 gram powder (Clear), two (2) 60 milliliter liquids, and one (1) 30 millilit |
| D001N8120000 | Contains one (1) 120 gram powder (Pink), two (2) 60 milliliter liquids, and one (1) 30 millilite |
| D001N8116000 | Contains one (1) PermaSoft® Combination Kit (N811500) and one (1) PermaSoft® Trial Kit (N81140 |
| D001N8115000 | Contains one (1) 60 gram powder (Pink), one (1) 30 gram powder (Clear), one (1) 60 milliliter li |
| D001N8114000 | Contains one (1) 30 gram PermaSoft Powder Pink (N815001), one (1) 30 milliliter PermaSoft Liquid |
| D001N8111000 | Contains one (1) 60 gram powder (N815102), one (1) 60 milliliter liquid (N814002), and one (1) 3 |
| D001N8110000 | Contains one (1) 60 gram powder (N815002), one (1) 60 milliliter liquid (N814002), and one (1) 3 |
Trademark Results [PermaSoft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERMASOFT 85743851 4371203 Live/Registered |
Sonny's Enterprises, Inc. 2012-10-02 |
 PERMASOFT 78450251 2989776 Dead/Cancelled |
Spectrum Hearing Systems, Inc. 2004-07-13 |
 PERMASOFT 76389023 2778501 Live/Registered |
ENGINEERED FLOORS, LLC 2002-04-01 |
 PERMASOFT 74445264 1886634 Live/Registered |
HOPKINS MANUFACTURING CORPORATION 1993-10-08 |
 PERMASOFT 74402715 1859425 Live/Registered |
NU TECHNOLOGIES, INC. 1993-06-17 |
 PERMASOFT 73560164 not registered Dead/Abandoned |
USA LENS, INC. 1985-09-26 |
 PERMASOFT 73376821 1253525 Dead/Cancelled |
La Maur Inc. 1982-07-26 |
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