510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182017Substantially Equivalent

Compex HD

Addent, Inc., Danbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182017 is the FDA 510(k) clearance record for Compex HD, a class I device, cleared for Addent, Inc. on under FDA product code QGO (Composite Resin Warmer). FDA's definition for product code QGO reads: "Intended to warm composite materials prior to use". FDA records list 7 510(k) clearances for Addent, Inc., from to . As of , FDA records show no recalls naming K182017.

Clearance record

Decision date
Received
(276 days to decision)
Product code
QGO Composite Resin Warmer
Regulation
21 CFR 872.6100
Device class
Class I
Review panel
Dental
Applicant
Addent, Inc. 43 Miry Brook Rd., Danbury CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QGO

Trailing 12 months

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

FDA records show no clearances under product code QGO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QGO, 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