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510(k) K852906

DURACLEAN DENTURE CLEANER by Astron Dental Corp. — Product Code JER

K852906 is an FDA 510(k) premarket notification submitted by Astron Dental Corp. for the device "DURACLEAN DENTURE CLEANER". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code JER (Cleaner, Denture, Mechanical), a Class I device regulated under 21 CFR 872.3530. Astron Dental Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Denture, Mechanical
Device Class
Class I
Regulation Number
872.3530
Review Panel
DE
Submission Type

Other clearances by Astron Dental Corp.

  • K874025 — 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN (December 23, 1987)
  • K864757 — MODIFIED VINYLAC PRESS PACK DENTURE RESIN (February 10, 1987)
  • K833270 — ASTRON 77 INJECTION DENTURE RESIN (July 19, 1984)
  • K831269 — VINYLAC PRESS-PACK DENTURE RESIN (June 8, 1983)

Other clearances for product code JER

  • K883403 — DENTA PLUS (October 25, 1988)
  • K881391 — ULTRASONIC DENTURE CLEANER (August 26, 1988)
  • K872521 — DENTURE CLEANSERS (August 11, 1987)
  • K840805 — ORAL SAFE (March 30, 1984)
  • K832359 — ORAL SAFE (September 26, 1983)
  • K832387 — DENTURE CLEANER (September 12, 1983)
  • K800166 — DENTSPLY DENTURE CLEANER (March 17, 1980)
  • K792530 — PLAQUE-X DENTURE CLEANER (December 27, 1979)
  • K791925 — DEN-MAT 4-MINUTE DENTURE CLEANER (October 26, 1979)
  • K791716 — PLAQUE-X DENTURE CLEANSER (October 23, 1979)

FDA data resources