International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive 60-05

GUDID D801ID6005I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive
Primary Device IDD801ID6005I1
NIH Device Record Key97f5c790-54ee-4294-a65e-79b373497c35
Commercial Distribution StatusIn Commercial Distribution
Brand NameInternational Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive
Version Model NumberID 60-05 I
Catalog Number60-05
Company DUNS096010525
Company NameSCIENTIFIC PHARMACEUTICALS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-634-3047
EmailDenise@scipharm.com
Phone800-634-3047
EmailDenise@scipharm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801ID6005I1 [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 Date2016-08-11

On-Brand Devices [International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive]

D801ID6005I1CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
D801ID60052I1CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
D801ID60051I1CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.

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