FDA.reportPublic FDA data

CERAMIC BRACKET ICERAM ROTH 0.018 - L4R(44) - 1UN

Primary DI
07898488902519
Brand
CERAMIC BRACKET ICERAM ROTH 0.018 - L4R(44) - 1UN
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
10.80.1144
Device description
CERAMIC BRACKET ICERAM ROTH 0.018 - L4R(44) - 1UN
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NJMBracket, Ceramic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222847000Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos2023-05-04NJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898488902519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898488902519078984889025197898488902519

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898330003
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898488900621KIT THERMO 35° WIRES - ROUNDS + RECTANGULARS - 100 TENS51.35.28012026-05-27
07898488905107WEINGART PLIER W/OUT WIDIA75.01.01212026-05-27
07898488905190INSTRUMENT FOR ICERAM SLB BRACKET75.00.00012026-05-27
07898488907217TUBE CONVERSION PLIER – 400375.01.05152026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVER75.00.00042026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)75.01.11552026-05-27
07908470705803TORQUE PLIER SHORT (442)75.01.00232026-05-27
07908470707135ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 1/4 - SILMET60.01.20082026-05-27
07908470707142ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 3/16 - SILMET60.01.20072026-05-27
07908470707159ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 1/4 - SILMET60.01.10082026-05-27
07908470707166ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 3/16 - SILMET60.01.10072026-05-27
07908611200129PLIER FOR LONG TORQUE (442)75.01.08062026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UN75.80.10062026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIER75.01.00042026-05-27
07908611205964ORTHOMETRIC ELASTIC STICK LIGATURE - ORANGE60.03.10562026-05-27
07908611207944KIT ELASTOMERIC - STICK LIGATURES - 23 COLORS60.03.29102026-05-27
07908611207951KIT ELASTOMERIC - ELASTIC CHAIN 1,5M - MEDIUM - 23 COLORS60.05.29102026-05-27
07908611207968KIT ELASTOMERIC - MODULAR LIGATURE 22 TIES - 10 COLORS60.06.29102026-05-27
07908611210654ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - CARIBBEAN BLUE60.05.70592026-05-27
07908611210715ORTHOMETRIC ELASTIC STICK LIGATURE - CORAL60.03.10572026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210067PROMO KIT ICERAM-P ROTH 0.022ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2024-04-16
08800046016025VAR-18-301GNI Co.,LtdNJM2022-12-14
08800046016032VAR-18-331GNI Co.,LtdNJM2022-12-14
08800046016049VAR-18-051GNI Co.,LtdNJM2022-12-14
08800046016056VAR-18-501GNI Co.,LtdNJM2022-12-14
08800046016063VAR-18-551GNI Co.,LtdNJM2022-12-14
08800046016070VAR-18-053GNI Co.,LtdNJM2022-12-14
08800046016087VAR-18-503GNI Co.,LtdNJM2022-12-14
08800046016094VAR-18-553GNI Co.,LtdNJM2022-12-14
08800046016100VAR-22-031GNI Co.,LtdNJM2022-12-14
08800046016117VAR-22-301GNI Co.,LtdNJM2022-12-14
08800046016124VAR-22-331GNI Co.,LtdNJM2022-12-14
08800046016131VAR-22-051GNI Co.,LtdNJM2022-12-14
08800046016148VAR-22-501GNI Co.,LtdNJM2022-12-14
08800046016155VAR-22-551GNI Co.,LtdNJM2022-12-14
08800046016162VAR-22-053GNI Co.,LtdNJM2022-12-14
08800046016179VAR-22-503GNI Co.,LtdNJM2022-12-14
08800046016193VAM-18-031GNI Co.,LtdNJM2022-12-14
08800046016209VAM-18-301GNI Co.,LtdNJM2022-12-14
08800046016216VAM-18-331GNI Co.,LtdNJM2022-12-14
08800046016223VAM-18-051GNI Co.,LtdNJM2022-12-14
08800046016230VAM-18-501GNI Co.,LtdNJM2022-12-14
08800046016247VAM-18-551GNI Co.,LtdNJM2022-12-14
08800046016254VAM-18-053GNI Co.,LtdNJM2022-12-14
08800046016261VAM-18-503GNI Co.,LtdNJM2022-12-14
08800046016278VAM-18-553GNI Co.,LtdNJM2022-12-14
08800046016285VAM-22-031GNI Co.,LtdNJM2022-12-14
08800046016292VAM-22-301GNI Co.,LtdNJM2022-12-14
08800046016308VAM-22-331GNI Co.,LtdNJM2022-12-14
08800046016315VAM-22-051GNI Co.,LtdNJM2022-12-14