Home GUDID D7854035SB0 SCAN BODY
Primary DI D7854035SB0
Brand SCAN BODY
Company OCO BIOMEDICAL INC
Model 4.0MM ENGAGE SCAN BODY
Catalog number 4035 SB
Device description 4.0MM ENGAGE SCAN BODY
Published 2024-03-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D7854035SB0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental implant abutment analog, scanning A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.
Regulatory Flags# DUNS number 094146123 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D785OTCAP100 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT OT CAP 10 OT CAP 10 2026-02-04 D785OTCAP40 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT OT CAP 4 OT CAP 4 2026-02-04 D785OTPINK40 4 PACK OT EQUATOR PINK INSERTS OT PINK 4 OT PINK 4 2026-02-04 D785OTPU20 2 PACK OT EQUATOR IMPRESSION COPING OT PU 2 OT PU 2 2026-02-04 D785OTYELLOW40 4 PACK OT EQUATOR YELLOW INSERT OT YELLOW 4 OT YELLOW 4 2026-02-04 D78589490 TSI/ERI Locator Abutment Locator Abutment 0mm 8949 2025-09-03 D785325SB0 SCAN BODY TSI/ERI 3.25MM SCAN BODY 3.25 SB 2024-06-26 D78540SB0 SCAN BODY TSI/ERI 4.0MM SCAN BODY 4.0 SB 2024-06-26 D78550SB0 SCAN BODY TSI/ERI 5.0MM SCAN BODY 5.0 SB 2024-06-26 D78532530SA0 SCAN ADAPTER 3.25MM ENGAGE PEEK SCAN ADAPTER 32530 SA 2024-03-12 D78532530SB0 SCAN BODY 3.25MM ENGAGE SCAN BODY 32530 SB 2024-03-12 D7854035SA0 SCAN ADAPTER 4.0MM ENGAGE PEEK SCAN ADAPTER 4035 SA 2024-03-12 D7855045SA0 SCAN ADAPTER 5.0MM ENGAGE PEEK SCAN ADAPTER 5045 SA 2024-03-12 D7855045SB0 SCAN BODY 5.0MM ENGAGE SCAN BODY 5045 SB 2024-03-12 D7856057SA0 SCAN ADAPTER 6.0MM ENGAGE PEEK SCAN ADAPTER 6057 SA 2024-03-12 D7856057SB0 SCAN BODY 6.0MM ENGAGE SCAN BODY 6057 SB 2024-03-12 D7850330T0 Osteotomy Former 3.3mm Osteotomy Former 0330TN 2024-12-03 D7853610ENGAGE0 Two Stage Bone Level Dental Implant Engage 3610 ENGAGE 2024-12-03 D7853610ENGPLS0 Two Stage Bone Level Implant Engage Plus 3610 Engage Plus 2024-12-03 D7853612ENGAGE0 Two Stage Bone Level Dental Implant Engage 3612 ENGAGE 2024-12-03
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