510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853358Substantially Equivalent

Reliance Pendulum Ophthalmic Delivery System

Dentsply Intl., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853358 is the FDA 510(k) clearance record for RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM, a class I device, cleared for Dentsply Intl. on under FDA product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K853358.

Clearance record

Decision date
Received
(53 days to decision)
Product code
HMF Stand, Instrument, Ac-Powered, Ophthalmic
Regulation
21 CFR 886.1860
Device class
Class I
Review panel
Ophthalmic
Applicant
Dentsply Intl. 96 Caldwell Dr., Cincinnati OH
Third party review
No

Clearances, product code HMF

Trailing 12 months

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

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