FDA.reportPublic FDA data

Advance Dental Products

Primary DI
00371347016307
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
APIMLR5H
Device description
Pure Ice Ceramic Brackets, MBT .022, LR5H, Tooth 45
Published
2024-11-15
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
00371347016307PrimaryGS10
10371347016304Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00371347016307003713470163073713470163070371347016307
1037134701630410371347016304

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
033505389
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00371347022292Advance Dental Products826262026-07-08
00371347023398Advance Dental Products10001212026-07-08
00371347023404Advance Dental Products10001222026-07-08
00371347023411Advance Dental Products10001232026-07-08
10371347023609Advance Dental Products859-012C2026-04-16
00371347019902Advance Dental Products8000012026-04-16
10371347023111Advance Dental ProductsARA-0012026-04-14
10371347023128Advance Dental ProductsARA-0022026-04-14
10371347023135Advance Dental ProductsARA-0032026-04-14
10371347023142Advance Dental ProductsARA-0042026-04-14
10371347023159Advance Dental ProductsARA-0052026-04-14
10371347023166Advance Dental ProductsARA-0062026-04-14
10371347023173Advance Dental ProductsARA-0072026-04-14
10371347023180Advance Dental ProductsARA-0082026-04-14
10371347023197Advance Dental ProductsARA-0092026-04-14
10371347023203Advance Dental ProductsARA-0102026-04-14
10371347023210Advance Dental ProductsARA-0112026-04-14
10371347023227Advance Dental ProductsARA-0122026-04-14
10371347023234Advance Dental ProductsARA-0132026-04-14
10371347023241Advance Dental ProductsARA-0142026-04-14

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
07895742282103MorelliDental Morelli LtdaNJM2023-11-14
07895742282110MorelliDental Morelli LtdaNJM2023-11-14
07895742282127MorelliDental Morelli LtdaNJM2023-11-14
07895742282134MorelliDental Morelli LtdaNJM2023-11-14
07895742282141MorelliDental Morelli LtdaNJM2023-11-14
07895742282158MorelliDental Morelli LtdaNJM2023-11-14
07895742282165MorelliDental Morelli LtdaNJM2023-11-14
07895742282172MorelliDental Morelli LtdaNJM2023-11-14
07895742282189MorelliDental Morelli LtdaNJM2023-11-14
07895742282196MorelliDental Morelli LtdaNJM2023-11-14
07895742282202MorelliDental Morelli LtdaNJM2023-11-14
07895742282219MorelliDental Morelli LtdaNJM2023-11-14
07895742282226MorelliDental Morelli LtdaNJM2023-11-14
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