FDA.reportPublic FDA data

Intrigue

Primary DI
00817573021925
Brand
Intrigue
Company
LANCER ORTHODONTICS, INC.
Model
231-522
Device description
OPTYC MBT CUS HK 0T +8A 022 UL
Published
2016-12-04
Public version status
Update
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
K902075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902075000INTRIGUE CERAMIC BRACKETLancer Orthodontics, Inc.1990-08-06NJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817573021925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817573021925008175730219258175730219250817573021925

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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
045545589
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817573022816NA551-4022017-01-12
00817573022823NA551-402RM2017-01-12
00817573022830NA551-4032017-01-12
00817573022847NA551-403RM2017-01-12
00817573022878NA551-7352017-01-12
00817573022885NA551-9252017-01-12
00817573024551NASAMS122017-01-15
00817573022892NA810-2112017-01-12
00817573022977NA810-5022017-01-12
00817573022984NA810-5032017-01-12
00817573022991NA810-5102017-01-12
00817573023004NA810-5222017-01-12
00817573023011NA810-5232017-01-12
00817573023028NA810-5242017-01-12
00817573023035NA810-5252017-01-12
00817573023042NA810-5262017-01-12
00817573023059NA810-5272017-01-12
00817573023066NA810-5282017-01-12
00817573023073NA810-5292017-01-12
00817573023189Rely-a-Bond811-0022017-01-12

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