CERAMIC BRACKET ICERAM-P MBT 0.018 - L5L(35) - 1UN

GUDID 07908611215819

CERAMIC BRACKET ICERAM-P MBT 0.018 - L5L(35) - 1UN

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic bracket, ceramic
Primary Device ID07908611215819
NIH Device Record Key073e80fd-e8ff-4a5c-9bdf-7b15f025b4c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERAMIC BRACKET ICERAM-P MBT 0.018 - L5L(35) - 1UN
Version Model Number10.93.1135
Company DUNS898330003
Company NameORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107908611215819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-19
Device Publish Date2025-12-11

Devices Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

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07908611211590 - ORTHODONTIC ELASTIC - INTRAORAL - BLACK LATEX - MEDIUM 3/8 - 1000UN2025-12-26 ORTHODONTIC ELASTIC - INTRAORAL - BLACK LATEX - MEDIUM 3/8 - 1000UN
07908611211606 - ORTHODONTIC ELASTIC INTRAORAL - BLACK LATEX BOX - MEDIUM 3/8 - 50X1002025-12-26 ORTHODONTIC ELASTIC INTRAORAL - BLACK LATEX BOX - MEDIUM 3/8 - 50X100
07908611211613 - ORTHODONTIC ELASTIC INTRAORAL - BLACK LATEX BOX - MEDIUM 3/16 - 50X1002025-12-26 ORTHODONTIC ELASTIC INTRAORAL - BLACK LATEX BOX - MEDIUM 3/16 - 50X100

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