510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953628Substantially Equivalent

Prophy Angle

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

K953628 is the FDA 510(k) clearance record for PROPHY ANGLE, a class I device, cleared for Rolence Enterprise Co. , Ltd. on under FDA product code EHK (Cup, Prophylaxis). FDA records list 14 510(k) clearances for Rolence Enterprise Co. , Ltd., from to . As of , FDA records show no recalls naming K953628.

Clearance record

Decision date
Received
(60 days to decision)
Product code
EHK Cup, Prophylaxis
Regulation
21 CFR 872.6290
Device class
Class I
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 EHK

Trailing 12 months

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

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