FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)

K Number: K896501 · Decision Feb 9, 1990
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
31
Review Days
87

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K Number
K896501
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3710
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Leach and Dillon Co., Inc.
Date Received
November 14, 1989
Decision Date
February 9, 1990
Product Code
EJH
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EJH Alloy, Metal, Base

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EJH), ordered by most recent decision date.

View all

Other Clearances by Leach and Dillon Co., Inc.

K Number Device Name
K903538 WIRON 99 DENTAL CASTING ALLOY
K903537 250 SL DENTAL CASTING ALLOY
K895059 HIGH FUSING YELLOW CERAMIC SOLDER
K895058 HIGH FUSING WHITE CERAMIC SOLDER
K903484 SELECT 20, DENTAL ALLOY
K902372 SILVER-FREE CERAMIC SOLDER (SFCS)
K902373 200 SILHOUETTE LINE (SL) CERAMIC SOLDER
K895888 SILHOUETTE PORCELAIN
K895889 SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895066 MONOGRAM IV
Search all 31 clearances from Leach and Dillon Co., Inc. →