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 ID10810000524270
NIH Device Record Key534c0dc1-b1aa-44eb-af17-578e86ef2a3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMucoSoft™
Version Model NumberS495
Catalog NumberS495
Company DUNS009900424
Company NamePARKELL, INC.
Device Count6
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000524273 [Unit of Use]
GS110810000524270 [Primary]

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-12-04
Device Publish Date2019-08-16

Devices Manufactured by PARKELL, INC.

00810000525744 - OTC2024-07-08 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
MUCOSOFT
75797160 2678529 Live/Registered
Parkell, Inc.
1999-09-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.