FDA.reportPublic FDA data

SA1610C

Primary DI
08800046000710
Brand
SA1610C
Company
GNI Co.,Ltd
Model
SA1610C
Published
2022-12-13
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
OATImplant, Endosseous, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046000710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046000710088000460007108800046000710

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic anchoring screwA small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694828541
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800046051484SS650SS6502025-04-04
08800046051309SSBC-M22-464GSSBC-M22-464G2024-06-18
08800046051316SSBC-M22-364GSSBC-M22-364G2024-06-18
08800046051323SSBC-M22-264GSSBC-M22-264G2024-06-18
08800046051330SSBC-M22-164GSSBC-M22-164G2024-06-18
08800046051385SSBC-M22-1M44GSSBC-M22-1M44G2024-06-18
08800046027540IES1-1001IES1-10012024-06-04
08800046045896P01-01P01-012024-06-04
08800046046602SN02-1018SN02-10182024-06-04
08800046050357ELT-01ELT-012024-06-04
08800046000642SA1208CSA1208C2022-12-13
08800046000659SA1210CSA1210C2022-12-13
08800046000666SA1406CSA1406C2022-12-13
08800046000673SA1408CSA1408C2022-12-13
08800046000680SA1410CSA1410C2022-12-13
08800046000697SA1606CSA1606C2022-12-13
08800046000703SA1608CSA1608C2022-12-13
08800046000727SA1806CSA1806C2022-12-13
08800046000734SA1808CSA1808C2022-12-13
08800046000741SA1810CSA1810C2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873099689BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099771BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099788BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100057BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100064BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100071BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100088BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100248BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100255BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100262BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100279BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100286BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100354BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100361BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100378BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100385BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873093021BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873098736BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099580BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099597BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099603BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099610BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099627BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099634BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099641BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12