510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K133592Substantially Equivalent

Neodent Implant System, Titamax Ti Ex Acqua and Ti Drive Acqua, Titamax Smart Ex Acqua and Drive Smart Acqua, Titamax Cm

Neodent USA, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133592 is the FDA 510(k) clearance record for NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM, a class II device, cleared for Neodent USA, Inc. on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list one 510(k) clearance for Neodent USA, Inc. As of , FDA records show no recalls naming K133592.

Clearance record

Decision date
Received
(273 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Neodent USA, Inc. 60 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZE

Trailing 12 months
19 clearances under product code DZE in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code DZE, trailing twelve months
MonthClearances
November 20251
December 20254
January 20261
February 20262
March 20264
April 20260
May 20261
June 20264
July 20260
August 20261
September 20261
October 20260