510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983120Substantially Equivalent

Bicortical Screw

Oraltronics Marketing-Und Vertriebs GmbH, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983120 is the FDA 510(k) clearance record for BICORTICAL SCREW, a class II device, cleared for Oraltronics Marketing-Und Vertriebs GmbH on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list one 510(k) clearance for Oraltronics Marketing-Und Vertriebs GmbH. As of , FDA records show no recalls naming K983120.

Clearance record

Decision date
Received
(328 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Oraltronics Marketing-Und Vertriebs GmbH 4329 Graydon Rd., San Diego CA
510(k) summary
Summary
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