510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950299Substantially Equivalent

Cerec 2

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

K950299 is the FDA 510(k) clearance record for CEREC 2, a class II device, cleared for Pelton & Crane Co. on under FDA product code ELW (Material, Impression). FDA records list 21 510(k) clearances for KaVo Dental Technologies, LLC, from to . As of , FDA records show no recalls naming K950299.

Clearance record

Decision date
Received
(118 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Pelton & Crane Co. P.O. Box 7800, Charlotte NC
510(k) summary
Statement
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260