OraSeal 351

GUDID 00883205103499

OraSeal Caulking Refill

ULTRADENT PRODUCTS, INC.

Rubber dam, non-latex
Primary Device ID00883205103499
NIH Device Record Key20e7883a-43ae-41c8-b437-451d9523a17f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOraSeal
Version Model Number351
Catalog Number351
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)572-4200
Emailcustomerservice@ultradent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205103499 [Primary]

FDA Product Code

EIEDAM, RUBBER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-23

On-Brand Devices [OraSeal]

00883205103543OraSeal Putty Econo Refill
00883205103499OraSeal Caulking Refill
00883205103482OraSeal Kit
00883205103475OraSeal Putty Refill
00883205103031OraSeal Caulking Econo Refill

Trademark Results [OraSeal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORASEAL
ORASEAL
75369506 2202904 Live/Registered
ULTRADENT PRODUCTS, INC.
1997-08-20
ORASEAL
ORASEAL
73830844 1652978 Dead/Cancelled
ULTRADENT PRODUCTS INCORPORATED
1989-10-12

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