MucoSoft™ S495
GUDID 10810000524270
Disposable 2-1/8” Brushes for MucoSoft™ & MucoHard™ (Pkg. of 6)
PARKELL, INC.
Dental material application tool, single-use| Primary Device ID | 10810000524270 |
| NIH Device Record Key | 534c0dc1-b1aa-44eb-af17-578e86ef2a3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MucoSoft™ |
| Version Model Number | S495 |
| Catalog Number | S495 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 6 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000524273 [Unit of Use] |
| GS1 | 10810000524270 [Primary] |
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 | 3 |
| Public Version Date | 2023-12-04 |
| Device Publish Date | 2019-08-16 |
Devices Manufactured by PARKELL, INC.
| 00810000525744 - OTC | 2024-07-08 OTC Remover in 4 Liter Bottle |
| 10810000525086 - Dryz™ | 2024-04-03 Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) |
| 00810000525720 - HyperFIL® | 2024-03-11 Hyperfil® 3ml Universal Shade |
| 00810000525737 - HyperFIL® | 2024-03-11 Hyperfil® 3ml Enamel Shade |
| 10810000527585 - 20/20™ | 2024-01-29 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.) |
| 10810000524409 - Cinch™ | 2024-01-26 Cinch® Plus Ultra-Light Wash (2-Cartridges & Tips) |
| 10810000524416 - Cinch™ | 2024-01-26 Quick Cinch® Plus Ultra-Light Wash (2-Cartridges & Tips) |
| 10810000524133 - Mach-2® | 2024-01-25 Mach-2® Die Silicone |
Trademark Results [MucoSoft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUCOSOFT 75797160 2678529 Live/Registered |
Parkell, Inc. 1999-09-10 |
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