510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022038Substantially Equivalent

Spi Onetime Dental Implant

Paxmed International, LLC, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022038 is the FDA 510(k) clearance record for SPI ONETIME DENTAL IMPLANT, a class II device, cleared for Paxmed International on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list 4 510(k) clearances for Paxmed International, from to . As of , FDA records show no recalls naming K022038.

Clearance record

Decision date
Received
(21 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Paxmed International 4329 Graydon Rd., San Diego CA
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