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

SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)

K Number: K895889 · Decision Apr 4, 1990
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
31
Review Days
181

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Basic Information

Device Name
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K Number
K895889
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.6660
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Leach and Dillon Co., Inc.
Date Received
October 5, 1989
Decision Date
April 4, 1990
Product Code
EIH
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
EIH Powder, Porcelain

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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
K895066 MONOGRAM IV
K896501 TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
Search all 31 clearances from Leach and Dillon Co., Inc. →