FDA.report

IMPRESSION COPING SPLINE

Primary DI
D785325ICSP0
Brand
IMPRESSION COPING SPLINE
Company
OCO BIOMEDICAL INC
Model
3.25MM TSI/ERI INDEXING IMPRESSION COPING TITANIUM
Catalog number
3.25 IC (SPLINE)
Device description
3.25MM TSI/ERI INDEXING IMPRESSION COPING (TITANIUM)
Published
2024-02-26
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D785325ICSP0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant abutment impression capA small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
094146123
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company

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
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
D7853612ENGAGE0Two Stage Bone Level Dental ImplantEngage3612 ENGAGE2024-12-03
D7853612ENGPLS0Two Stage Bone Level ImplantEngage Plus3612 Engage plus2024-12-03
D7853614ENGAGE0Two Stage Bone Level Dental ImplantEngage3614 ENGAGE2024-12-03
D7853614ENGPLS0Two Stage Bone Level ImplantEngage Plus3614 Engage Plus2024-12-03
D7853616ENGAGE0Two Stage Bone Level Dental Implant Engage3616 ENGAGE2024-12-03
D7853616ENGPLS0Two Stage Bone Level ImplantEngage Plus3616 Engage Plus2024-12-03
D785SURGICALGUIDE0SURGICAL GUIDE3D PRINTED SURGICAL GUIDESURGICAL GUIDE2024-12-03
D7856006ENGPLS0Two Stage Bone Level ImplantEngage Plus6006 Engage Plus2024-09-27
D785293325CBTI0SDI Crown and Bridge Abutments (Ti)2.9/3/3.25MM SDI C&B ABUTMENT2.9/3/3.25 CB (Ti)2024-06-28
D785SDI2225CBTI0SDI Crown and Bridge Abutments (Ti)2.2/2.5MM SDI C&B ABUTMENTSDI 2.2/2.5 CB (Ti)2024-06-28
D785002CAPWOBN0HOUSING CAP WITH O-RING002 CAP W/O-RING (002BN900)002 CAP W/O-RING (002BN900)2024-06-26

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