510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980793Substantially Equivalent

Q-Luxpro V/q-Luxpro II Light Cure Unit

Rolence Enterprise Co., Ltd., Chungli, Taiwan, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980793 is the FDA 510(k) clearance record for Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT, a class II device, cleared for Rolence Enterprise Co. , Ltd. on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 14 510(k) clearances for Rolence Enterprise Co. , Ltd., from to . As of , FDA records show no recalls naming K980793.

Clearance record

Decision date
Received
(74 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Rolence Enterprise Co. , Ltd. 226 Kong-Shieh-Sir Village, Chungli, Taiwan, TW
510(k) summary
Statement
Third party review
No

Clearances, product code EBF

Trailing 12 months
19 clearances under product code EBF in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260