FDA.reportPublic FDA data

NA

Primary DI
H98004500028050
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
04.500.028.05
Catalog number
0450002805
Device description
TI OBA PLATE ANCHOR SCREW SELF-DRILLING 8MM
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K063473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063473000SYNTHES ORTHODONTIC BONE ANCHOR SYSTEMSynthes (Usa)2007-03-08OAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887587016631PrimaryGS10
H98004500028050SecondaryHIBCC0
80887587016633Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088758701663120887587016631
8088758701663380887587016633

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

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
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
04719873099658BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099665BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099672BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099726BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12