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.
| 00810000525751 - HyperFIL® | 2025-04-07 HyperFIL® + A3/A3.5/B3 - 2.5ml |
| 00810000525768 - HyperFIL® | 2025-04-07 HyperFIL® + A1/B1 - 10ml |
| 00810000525775 - HyperFIL® | 2025-04-07 HyperFIL® + A2/B2 - 10ml |
| 10810000520319 - Integra™ | 2025-03-17 Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps) |
| 00810000521579 - PureClarity™ | 2024-12-23 PureClarity™ Waterline Purification Filter |
| 00810000521647 - PureClarity™ | 2024-12-23 PureClarity™ Purification Filter - Installation Kit |
| 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) |
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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