FDA.reportPublic FDA data

ORTHOMETRIC BANDS

Primary DI
07908470700518
Brand
ORTHOMETRIC BANDS
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
40.01.0395
Catalog number
40.01.0395
Device description
ORTHODONTIC BANDS- LOWER 39,5 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

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
07908470700518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908470700518079084707005187908470700518

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
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 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
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D866HCCP40BG0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCP40BO0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCP40BPK0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCSK40ANB0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCSK40ANG0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCSK40ANO0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCSK40ANP0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCSK40ANPK0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCY40B0P0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCY40BB0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCY40BG0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCY40BO0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866HCCY40BPK0Ortho-Tain, IncOrtho-Tain, IncDYO2025-05-12
D866MOUTHGUARDB0KGuard ProOrtho-Tain, IncDYO2025-03-18
D866MOUTHGUARDG0KGuard ProOrtho-Tain, IncDYO2025-03-18
D866MOUTHGUARDO0KGuard ProOrtho-Tain, IncDYO2025-03-18
D866MOUTHGUARDP0KGuard ProOrtho-Tain, IncDYO2025-03-18
D866MOUTHGUARDPK0KGuard ProOrtho-Tain, IncDYO2025-03-18
D866MOUTHGUARDBLUE0KGuard ProOrtho-Tain, IncDYO2025-01-09
D866MOUTHGUARDGREEN0KGuard ProOrtho-Tain, IncDYO2025-01-09
D866MOUTHGUARDORANGE0KGuard ProOrtho-Tain, IncDYO2025-01-09
D866MOUTHGUARDPINK0KGuard ProOrtho-Tain, IncDYO2025-01-09
D866MOUTHGUARDPURPLE0KGuard ProOrtho-Tain, IncDYO2025-01-09
00840273919063Bands & AttachmentsWorld Class Technology CorporationDYO2024-03-14
00840273919070Bands & AttachmentsWorld Class Technology CorporationDYO2024-03-14
00840273919087Bands & AttachmentsWorld Class Technology CorporationDYO2024-03-14
00840273919094Bands & AttachmentsWorld Class Technology CorporationDYO2024-03-14
00840273919100Bands & AttachmentsWorld Class Technology CorporationDYO2024-03-14