FDA.reportPublic FDA data

Absoanchor Microimplant

Primary DI
08806145400352
Brand
Absoanchor Microimplant
Company
DENTOS Inc.
Model
SH1413-10
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060126000ABSOANCHOR MICROIMPLANTDentos, Inc.2006-05-16DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806145400352PrimaryGS10
08806145405357Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806145400352088061454003528806145400352
08806145405357088061454053578806145405357

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
688355973
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806145440105Dental ForcepCF2018-09-17
08806145440112Dental ForcepMCF2018-09-17
08806145465276Dental ForcepEF-L2018-09-17
08806145465283Dental ForcepEF-U2018-09-17
08806145440129Orthodontic DriverLHD-B+DT-L2025-05-02
08806145440136Orthodontic DriverLHD-B+DT-S2025-05-02
08806145440143Orthodontic DriverNLHD+ST-L2025-05-02
08806145440150Orthodontic DriverNLHD+ST-S2025-05-02
08806145440167Orthodontic DriverNLHD-S+ST-L2025-05-02
08806145440174Orthodontic DriverNLHD-S+ST-S2025-05-02
08806145484086Orthodontic DriverNLHD-S2025-05-02
08806145484895Plier, OrthodonticNTDP-T2025-05-02
08806145484901Plier, OrthodonticNTDP-S2025-05-02
08806145484918Plier, OrthodonticCBRP2025-05-02
08806145455192Orthodontic BracketMTB-12018-09-14
08806145455208Orthodontic BracketMTB-22018-09-14
08806145455215Orthodontic BracketTLB-L2018-09-14
08806145455222Orthodontic BracketTLB-U2018-09-14
08806145471352Orthodontic Bracket2in1-U-122018-06-08
08806145471369Orthodontic Bracket2in1-U-32018-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114712149prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712767prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712774prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712781prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712798prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712804prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712811prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712828prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712835prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712842prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712859prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712866prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712873prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712880prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712897prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712903prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712910prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712927prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712934prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712941prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712958prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712965prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713009prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713016prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713023prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713030prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713047prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713061prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713078prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713085prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06