FDA.reportPublic FDA data

IMPRESSION COPING/TEMPORARY ABUTMENT

Primary DI
D7856057ICTA0
Brand
IMPRESSION COPING/TEMPORARY ABUTMENT
Company
OCO BIOMEDICAL INC
Model
IMPRESSION COPING/TEMPORARY ABUTMENT- CLOSED/OPEN
Catalog number
6057 IC/TA
Device description
IMPRESSION COPING/TEMPORARY ABUTMENT- CLOSED/OPEN TRAY 5.7MM
Published
2024-03-12
Public version status
New
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090174000TSI; ERIOco Biomedical2009-09-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7856057ICTA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
094146123
Device count
1
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
D785OTCAP10010 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERTOT CAP 10OT CAP 102026-02-04
D785OTCAP404 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERTOT CAP 4OT CAP 42026-02-04
D785OTPINK404 PACK OT EQUATOR PINK INSERTSOT PINK 4OT PINK 42026-02-04
D785OTPU202 PACK OT EQUATOR IMPRESSION COPINGOT PU 2OT PU 22026-02-04
D785OTYELLOW404 PACK OT EQUATOR YELLOW INSERTOT YELLOW 4OT YELLOW 42026-02-04
D78589490TSI/ERI Locator AbutmentLocator Abutment 0mm89492025-09-03
D785325SB0SCAN BODYTSI/ERI 3.25MM SCAN BODY3.25 SB2024-06-26
D78540SB0SCAN BODYTSI/ERI 4.0MM SCAN BODY4.0 SB2024-06-26
D78550SB0SCAN BODYTSI/ERI 5.0MM SCAN BODY5.0 SB2024-06-26
D78532530SA0SCAN ADAPTER3.25MM ENGAGE PEEK SCAN ADAPTER32530 SA2024-03-12
D78532530SB0SCAN BODY3.25MM ENGAGE SCAN BODY32530 SB2024-03-12
D7854035SA0SCAN ADAPTER4.0MM ENGAGE PEEK SCAN ADAPTER4035 SA2024-03-12
D7854035SB0SCAN BODY4.0MM ENGAGE SCAN BODY4035 SB2024-03-12
D7855045SA0SCAN ADAPTER5.0MM ENGAGE PEEK SCAN ADAPTER5045 SA2024-03-12
D7855045SB0SCAN BODY5.0MM ENGAGE SCAN BODY5045 SB2024-03-12
D7856057SA0SCAN ADAPTER6.0MM ENGAGE PEEK SCAN ADAPTER6057 SA2024-03-12
D7856057SB0SCAN BODY6.0MM ENGAGE SCAN BODY6057 SB2024-03-12
D7850330T0Osteotomy Former3.3mm Osteotomy Former0330TN2024-12-03
D7853610ENGAGE0Two Stage Bone Level Dental ImplantEngage3610 ENGAGE2024-12-03
D7853610ENGPLS0Two Stage Bone Level ImplantEngage Plus3610 Engage Plus2024-12-03

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