Excel Fast 1EFSAF

GUDID D7981EFSAF0

Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part A with Fluoride in a 6gm syringe

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive
Primary Device IDD7981EFSAF0
NIH Device Record Key9930eaf6-cdc2-48cb-97f4-faa9241c94e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcel Fast
Version Model Number1EFSAF
Catalog Number1EFSAF
Company DUNS113170088
Company NameRELIANCE ORTHODONTIC PRODUCTS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C)

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7981EFSAF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-04

On-Brand Devices [Excel Fast]

D7981EFSB0Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part B in a
D7981EFSAF0Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part A with

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