IMPRESSION COPING/TEMPORARY ABUTMENT 6057 IC/TA

GUDID D7856057ICTA0

IMPRESSION COPING/TEMPORARY ABUTMENT- CLOSED/OPEN TRAY 5.7MM

OCO BIOMEDICAL INC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D7856057ICTA0
• NIH Device Record Key: b8890e8a-9605-435b-96e2-84d98b439acc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPRESSION COPING/TEMPORARY ABUTMENT
• Version Model Number: IMPRESSION COPING/TEMPORARY ABUTMENT- CLOSED/OPEN
• Catalog Number: 6057 IC/TA
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7856057ICTA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

[D7856057ICTA0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by OCO BIOMEDICAL INC

• D785AS3100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 3.25mm
• D785AS4100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 4.0/5.0mm
• D78529SDIOBPK0 - 2.9 SDI O-BALL PROSTHETIC KIT: 2024-04-29 2.9MM SDI O-BALL PROSTHETIC KIT
• D78540TPKOB0 - TSI PROSTHETIC KIT: 2024-04-25 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT
• D785325ICBPK0 - ISI C&B PROSTHETIC KIT: 2024-04-17 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
• D785002ORKIT0 - O-RING PACK: 2024-04-11 002 O-Ring Kit
• D785003ORKIT0 - O-RING PACK: 2024-04-11 003 O-Ring Kit
• D785002CAPWO0 - HOUSING CAP WITH O-RING: 2024-03-20 002 CAP WITH 002 BLK O-RING INSERTED