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510(k) K840805

ORAL SAFE by Great Lakes Orthodontics, Ltd. — Product Code JER

K840805 is an FDA 510(k) premarket notification submitted by Great Lakes Orthodontics, Ltd. for the device "ORAL SAFE". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code JER (Cleaner, Denture, Mechanical), a Class I device regulated under 21 CFR 872.3530. Great Lakes Orthodontics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
February 24, 1984
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 Great Lakes Orthodontics, Ltd.

  • K172765 — Smart Moves Complete (June 1, 2018)
  • K150702 — Exceed Tx (March 24, 2016)
  • K083479 — BIOCRYL X (February 27, 2009)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K040881 — METACRYL (May 25, 2004)
  • K033632 — VARIFLEX (January 21, 2004)
  • K922818 — SNORE-NO-MORE (February 9, 1994)
  • K925275 — SOFT DENTURE RELINE MATERIAL ELASTOLINE (January 11, 1993)
  • K870908 — STEADY RESIN (March 19, 1987)
  • K861424 — ADAPTABLE CLASS III MASK (May 29, 1986)

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)
  • K852906 — DURACLEAN DENTURE CLEANER (July 31, 1985)
  • 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