FDA.report

ORTHOMETRIC BANDS

Primary DI
07908470700303
Brand
ORTHOMETRIC BANDS
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
40.01.0290
Catalog number
40.01.0290
Device description
ORTHODONTIC BANDS- LOWER 29 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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DYOBand, Material, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908470700303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908470700303079084707003037908470700303

GMDN Terms

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

Regulatory Flags

DUNS number
898330003
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 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

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