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510(k) K831265

DENTOLOCK DENTURE ADHESIVE CREAM by Solar Dental Co., Inc. — Product Code KOQ

K831265 is an FDA 510(k) premarket notification submitted by Solar Dental Co., Inc. for the device "DENTOLOCK DENTURE ADHESIVE CREAM". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code KOQ (Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)), a Class I device regulated under 21 CFR 872.3410. Solar Dental Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
April 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Device Class
Class I
Regulation Number
872.3410
Review Panel
DE
Submission Type

Other clearances by Solar Dental Co., Inc.

  • K871980 — D-23 DENTURE ADHESIVE (June 5, 1987)
  • K861846 — HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (June 26, 1986)
  • K852926 — DENTOLOCK II DENTURE ADHESIVE CREAM (August 23, 1985)
  • K831294 — SOLARCRY/TEMPORARY CROWN & BRIDGE MAT (August 31, 1983)
  • K831293 — SOLARCRYL CUSTOM TRAY MATERIAL (July 26, 1983)

Other clearances for product code KOQ

  • K901882 — URESIL ENDOSCOPIC LASER OVERTUBE (July 27, 1990)
  • K900401 — NAS&P GRASPING FORCEPS & ASSOC. DEVICES (February 9, 1990)
  • K896821 — OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE (February 9, 1990)

FDA data resources