FDA.reportPublic FDA data

KIT CERAMIC BRACKET ICERAM-P MBT 0.022 - 1 SET + TUBES + WIRES

Primary DI
07908611211422
Brand
KIT CERAMIC BRACKET ICERAM-P MBT 0.022 - 1 SET + TUBES + WIRES
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
10.93.2903
Device description
KIT CERAMIC BRACKET ICERAM-P MBT 0.022 - 1 SET + TUBES + WIRES
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
07908611211422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908611211422079086112114227908611211422

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.

Regulatory Flags#

DUNS number
898330003
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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