510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033044Substantially Equivalent

Dream Cleanse S Scaler, Dream Compact S Scaler

American Green Dent. Mfg, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K033044 is the FDA 510(k) clearance record for DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER, a class II device, cleared for American Green Dent. Mfg, Inc. on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 2 510(k) clearances for American Green Dent. Mfg, Inc., from to . As of , FDA records show no recalls naming K033044.

Clearance record

Decision date
Received
(449 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
American Green Dent. Mfg, Inc. 3432 E. 14th St., Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code ELC

Trailing 12 months
2 clearances under product code ELC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ELC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260