510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K891119Substantially Equivalent

T.r.s.: Tooth Replacement System

Health Technology of America, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891119 is the FDA 510(k) clearance record for T.R.S.: TOOTH REPLACEMENT SYSTEM, a class I device, cleared for Health Technology of America, Inc. on under FDA product code EGG (Attachment, Precision, All). FDA records list one 510(k) clearance for Health Technology of America, Inc. As of , FDA records show no recalls naming K891119.

Clearance record

Decision date
Received
(46 days to decision)
Product code
EGG Attachment, Precision, All
Regulation
21 CFR 872.3165
Device class
Class I
Review panel
Dental
Applicant
Health Technology of America, Inc. 301 W. 53rd St., New York NY
Third party review
No

Clearances, product code EGG

Trailing 12 months

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

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