510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992582Substantially Equivalent

Pacific Implant Titanium Endodontic Point

Pacific Implant, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992582 is the FDA 510(k) clearance record for PACIFIC IMPLANT TITANIUM ENDODONTIC POINT, a class I device, cleared for Pacific Implant, Inc. on under FDA product code EKL (Point, Silver, Endodontic). FDA records list 2 510(k) clearances for Pacific Implant, Inc., from to . As of , FDA records show no recalls naming K992582.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EKL Point, Silver, Endodontic
Regulation
21 CFR 872.3840
Device class
Class I
Review panel
Dental
Applicant
Pacific Implant, Inc. 2000 M St., NW 7th Floor, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code EKL

Trailing 12 months

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

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