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

300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS

K Number: K895048 · Decision Dec 18, 1989
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
31
Review Days
132

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Basic Information

Device Name
300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K Number
K895048
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3060
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Leach and Dillon Co., Inc.
Date Received
August 8, 1989
Decision Date
December 18, 1989
Product Code
EJT
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
EJT Alloy, Gold-Based Noble Metal

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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. →