FDA.reportPublic FDA data

ACR Orthodontic Anchor Screw

Primary DI
08809744960005
Brand
ACR Orthodontic Anchor Screw
Company
BioMaterials Korea, Inc.
Model
OAS-T1207
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OATImplant, Endosseous, Orthodontic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063495000C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWSBiomaterials Korea, Inc.2007-07-26OAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809744960005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809744960005088097449600058809744960005

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689679066
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809233620106ACR Bone ScrewOSS-T15352026-05-11
08809233620113ACR Bone ScrewOSS-T15042026-05-11
08809233620120ACR Bone ScrewOSS-T15052026-05-11
08809233620137ACR Bone ScrewOSS-T15062026-05-11
08809233620144ACR Bone ScrewOSS-T15072026-05-11
08809233620151ACR Bone ScrewOSS-T15082026-05-11
08809233620168ACR Bone ScrewOSS-T15092026-05-11
08809233620182ACR Bone ScrewOSS-T15112026-05-11
08809233620199ACR Bone ScrewOSS-T15132026-05-11
08809233620205ACR Bone ScrewOSS-T15152026-05-11
08809233620298ACR Bone ScrewOSS-T20042026-05-11
08809233620304ACR Bone ScrewOSS-T20052026-05-11
08809233620311ACR Bone ScrewOSS-T20062026-05-11
08809233620335ACR Bone ScrewOSS-T20072026-05-11
08809233620342ACR Bone ScrewOSS-T20082026-05-11
08809233620366ACR Bone ScrewOSS-T20092026-05-11
08809233620380ACR Bone ScrewOSS-T20112026-05-11
08809233620397ACR Bone ScrewOSS-T20132026-05-11
08809233620403ACR Bone ScrewOSS-T20152026-05-11
08809233620410ACR Bone ScrewOSS-T20172026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011302112000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302114000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302212000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302214000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-30
J011302150000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-04
J011302250000tomas®DENTAURUM GmbH & Co.KGOAT2026-09-04
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
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