FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CONVENTIONAL PLASTIC DENTAL TRAYS

K Number: K841491 · Decision Jul 13, 1984
Classifications
1
FEI Numbers
317
Registration Numbers
317
Same Product Code
15
Applicant Total
11
Review Days
94

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Basic Information

Device Name
CONVENTIONAL PLASTIC DENTAL TRAYS
K Number
K841491
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6880
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Buffalo Dental Mfg. Co., Inc.
Date Received
April 10, 1984
Decision Date
July 13, 1984
Product Code
EHY
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
EHY Tray, Impression, Preformed

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Other Clearances by Buffalo Dental Mfg. Co., Inc.

K Number Device Name
K955573 OPTIBLAST INTRAORAL SANDBLASTER
K945220 AMALGAM CARRIER
K941954 NON-FOGGING DENTAL MIRROR
K841323 FUZZY TRAY
K841490 POLYSULFIDE CUSTOM TRAY MATERIAL
K820489 ULTRAFINE TRAY ADHESIVE
K820216 ULTRA-WET
K802990 ALGINATE/SILICONE CROWN & BRIDGE MATER
K802882 HYDROCOLLOID COMPATIBLE CREAM ALGINATE
K802662 POLYCARBONATE TEMPORARY CEMENT
Search all 11 clearances from Buffalo Dental Mfg. Co., Inc. →