FDA.reportPublic FDA data

ORTHOMETRIC BANDS

Primary DI
07908470700631
Brand
ORTHOMETRIC BANDS
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
40.02.0300
Catalog number
40.02.0300
Device description
ORTHODONTIC BANDS- UPPER 30 MM
Published
2022-09-28
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
DYOBand, Material, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908470700631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908470700631079084707006317908470700631

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic band materialA material typically supplied in the form of rolls, strips, or precut blanks with the attachments in place ready to be configured as orthodontic bands. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898330003
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UN10.10.23112026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UN10.10.23122026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UN10.10.23132026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UN10.10.23142026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UN10.10.23212026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UN10.10.23222026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UN10.10.23232026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UN10.10.23242026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UN10.10.23332026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UN10.10.23342026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UN10.10.23352026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UN10.10.23432026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UN10.10.23442026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UN10.10.23452026-05-26
07908470701294STAINLESS STEEL - WIRE ROUND 0.014 - UPPER - 12UN51.60.20142026-05-26
07908470701355STAINLESS STEEL - WIRE RECTANGULAR 0.019X0.025 - UPPER - 12UN51.60.25192026-05-26
07908470707678KIT LAUNCH - U-CLIP10.45.23012026-05-26
07908470708798KIT ARCHWIRE SEQUENCE HEAVY51.35.28032026-05-26
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UN10.84.22452026-05-26
07908611204103CERAMIC MINI TUBE -10UN21.02.20042026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974720061198Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061204Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061211Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061228Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061235Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061242Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
006522210247323M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-05-07
006522213044453M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213044523M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213029843M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213029913M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
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006522213030423M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
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006522213030663M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030733M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030803M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
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006522213031033M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031343M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031413M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031583M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031723M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031963M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032023M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032193M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032263M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-25