FDA.reportPublic FDA data

Indirect Bonding Tray

Primary DI
00817645020207
Brand
Indirect Bonding Tray
Company
Six Month Smiles
Model
700D
Published
2023-03-16
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
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817645020207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817645020207008176450202078176450202070817645020207

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance/positioning tray kitA collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118919669
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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008176450201776MS Aligners800-ALN2019-07-17
00817645020009OrthoFlow®904R904R2016-09-24
00817645020016OrthoMax®905R905R2016-09-24
00817645020023Lucid-Lok™20320-120320-12016-09-24
00817645020030Lucid-Lok™20301203012016-09-24
00817645020047Lucid-Lok™20302203022016-09-24
00817645020054Lucid-Lok™20303203032016-09-24
00817645020061Lucid-Lok™20304203042016-09-24
00817645020078Lucid-Lok™20305203052016-09-24
00817645020085Lucid-Lok™20306203062016-09-24
00817645020092Lucid-Lok™20307203072016-09-24
00817645020108Lucid-Lok™20308203082016-09-24
00817645020115Lucid-Lok™20311203112016-09-24
00817645020122Lucid-Lok™20312203122016-09-24
00817645020139Lucid-Lok™20313203132016-09-24
00817645020146Lucid-Lok™20321203212016-09-24
00817645020160OrthoMax®906R06R2018-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054154160013EQUILIBRATORE 1.0EPTAMED SRLKMY2026-07-28
08054154160020EQUILIBRATORE 1.05EPTAMED SRLKMY2026-07-28
08054154160037EQUILIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNGEPTAMED SRLKMY2026-07-28
08054154160143EQUILIBRATORE 3.2EPTAMED SRLKMY2026-07-28
08054154160150EQULIBRATORE 3.3EPTAMED SRLKMY2026-07-28
08054154160198EquiIlibratore C2EPTAMED SRLKMY2026-07-28
08054154160204Equilibratore C3EPTAMED SRLKMY2026-07-28
08054154160211Equilibratore C4EPTAMED SRLKMY2026-07-28
08054154160228EQUILIBRATORE C3PEPTAMED SRLKMY2026-07-28
08054154160259EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160266EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160273EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160297FREEDOMEPTAMED SRLKMY2026-07-28
08054154160303EQUILIBRATORE GENIUS 3EPTAMED SRLKMY2026-07-28
08054154160334EQUILIBRATORE NIKI 1EPTAMED SRLKMY2026-07-28
08054154160372EQUILIBRATORE 003EPTAMED SRLKMY2026-07-28
08054154160402EQUILIBRATORE SL3 YOUNGEPTAMED SRLKMY2026-07-28
08054154160426EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160433EQUILIBRATORE U4EPTAMED SRLKMY2026-07-28
08054154160501EQULIBRATORE U2EPTAMED SRLKMY2026-07-28
08054154160563EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160761EQUILIBRATORE NIKI 2EPTAMED SRLKMY2026-07-28
08054154160815EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160822EQUILIBRATORE GENIUS 2EPTAMED SRLKMY2026-07-28
08054154160945EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160969EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154161089EQULIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154161126EQUILIBRATORE C3P YOUNGEPTAMED SRLKMY2026-07-28
08054154161164EQULIBRATORE U4 YOUNGEPTAMED SRLKMY2026-07-28