FDA.report

SA1610

Primary DI
08800046000574
Brand
SA1610
Company
GNI Co.,Ltd
Model
SA1610
Published
2022-11-09
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
OATImplant, Endosseous, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800046000574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800046000574088000460005748800046000574

GMDN Terms

TermDefinition
Orthodontic anchoring screwA small metallic 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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694828541
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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
08800046000710SA1610CSA1610C2022-12-13
08800046000727SA1806CSA1806C2022-12-13
08800046000734SA1808CSA1808C2022-12-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05056091026851Infinitas Orthodontic Mini ImplantDB ORTHODONTICS LIMITEDOAT2025-08-13
05056091028602Infinitas Orthodontic Mini ImplantDB ORTHODONTICS LIMITEDOAT2025-08-13
07895742288501MorelliDental Morelli LtdaOAT2025-02-11
07895742288570MorelliDental Morelli LtdaOAT2025-02-11
08800197900631ATOZ Mini-ScrewMK Meditech Inc.OAT2024-12-18
08800197900648ATOZ Mini-ScrewMK Meditech Inc.OAT2024-12-18
08800197900655ATOZ Mini-ScrewMK Meditech Inc.OAT2024-12-18
08800197900662ATOZ Mini-ScrewMK Meditech Inc.OAT2024-12-18
08800197900679ATOZ Mini-ScrewMK Meditech Inc.OAT2024-12-18
08800197900686ATOZ Mini-ScrewMK Meditech Inc.OAT2024-12-18
D81990150009mm Mini Screw Button TypeSPECIALTY APPLIANCES, LLCOAT2024-11-19
D819901501011mm Mini Screw Button TypeSPECIALTY APPLIANCES, LLCOAT2024-11-19
D819901502013mm Mini Screw Button TypeSPECIALTY APPLIANCES, LLCOAT2024-11-19
D819901503015mm Mini Screw Button TypeSPECIALTY APPLIANCES, LLCOAT2024-11-19
D819901504017mm Mini Screw Button TypeSPECIALTY APPLIANCES, LLCOAT2024-11-19
08800197900198ATOZ Mini-ScrewMK Meditech Inc.OAT2024-01-12
08800046000642SA1208CGNI Co.,LtdOAT2022-12-13
08800046000659SA1210CGNI Co.,LtdOAT2022-12-13
08800046000666SA1406CGNI Co.,LtdOAT2022-12-13
08800046000673SA1408CGNI Co.,LtdOAT2022-12-13
08800046000680SA1410CGNI Co.,LtdOAT2022-12-13
08800046000697SA1606CGNI Co.,LtdOAT2022-12-13
08800046000703SA1608CGNI Co.,LtdOAT2022-12-13
08800046000710SA1610CGNI Co.,LtdOAT2022-12-13
08800046000727SA1806CGNI Co.,LtdOAT2022-12-13
08800046000734SA1808CGNI Co.,LtdOAT2022-12-13
08800046000741SA1810CGNI Co.,LtdOAT2022-12-13
08800046000758SA2006CGNI Co.,LtdOAT2022-12-13
08800046000765SA2008CGNI Co.,LtdOAT2022-12-13
08800046000772SA2010CGNI Co.,LtdOAT2022-12-13