510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860653Substantially Equivalent

Pure Titanium Screw-Type for Dental Implant

Otc/America, Wellesley Hills MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860653 is the FDA 510(k) clearance record for PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT, a class II device, cleared for Otc/America on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list 2 510(k) clearances for Otc/America, from to . As of , FDA records show no recalls naming K860653.

Clearance record

Decision date
Received
(55 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Otc/America 37 Walnut St., Wellesley Hills MA
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