510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771749Substantially Equivalent

Amalgam Dispenser

New Dimensions in Medicine, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771749 is the FDA 510(k) clearance record for AMALGAM DISPENSER, a class I device, cleared for New Dimensions IN Medicine, Inc. on under FDA product code EHE (Dispenser, Mercury And/Or Alloy). FDA records list 6 510(k) clearances for New Dimensions IN Medicine, Inc., from to . As of , FDA records show no recalls naming K771749.

Clearance record

Decision date
Received
(13 days to decision)
Product code
EHE Dispenser, Mercury And/Or Alloy
Regulation
21 CFR 872.3080
Device class
Class I
Review panel
Dental
Applicant
New Dimensions IN Medicine, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EHE

Trailing 12 months

FDA records hold no clearances under product code EHE in the trailing twelve months.

FDA records show no clearances under product code EHE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EHE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260