FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 1 results

510(k) Data Aggregation

K Number

Device Name

BIO 60

Manufacturer

KODENT, INC.

Date Cleared

2004-08-02

(70 days)

Product Code

EJT

Regulation Number

872.3060

Why did this record match?

Applicant Name (Manufacturer) :

KODENT, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.

Device Description

Gold cylinder for using UCLA Abutment

Ask a Question

Page 1 of 1