510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960819Substantially Equivalent

Heliodent Ds

KaVo Dental Technologies, LLC, Charlotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960819 is the FDA 510(k) clearance record for HELIODENT DS, a class II device, cleared for Pelton & Crane Co. on under FDA product code EAP (Unit, X-Ray, Intraoral). FDA records list 21 510(k) clearances for KaVo Dental Technologies, LLC, from to . As of , FDA records show no recalls naming K960819.

Clearance record

Decision date
Received
(29 days to decision)
Product code
EAP Unit, X-Ray, Intraoral
Regulation
21 CFR 872.1810
Device class
Class II
Review panel
Dental
Applicant
Pelton & Crane Co. 11727 Fruehauf Dr., Charlotte NC
510(k) summary
Statement
Third party review
No

Clearances, product code EAP

Trailing 12 months

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

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