Ortho Bite 4000019365

GUDID 07899633815982

Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment. The product is colored in order to facilitate its identification during application and removal.

Dentscare Ltda

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive
Primary Device ID07899633815982
NIH Device Record Key2db04e89-5d71-44ad-9ac2-15577334f34a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrtho Bite
Version Model Number4g
Catalog Number4000019365
Company DUNS898067533
Company NameDentscare Ltda
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899633815982 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-05
Device Publish Date2022-04-27

Devices Manufactured by Dentscare Ltda

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07899633827688 - Whitepost System2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
07899633827695 - Whitepost System2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
07899633827701 - Whitepost System2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
07899633831005 - Whitepost System2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
07899633827145 - Whitepost System2023-06-15 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
07899633827169 - Whitepost System2023-06-15 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
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