510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100854Substantially Equivalent

Premium Plus Disposable Prophy Angle Model 3399

Premium Plus International Limited, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K100854 is the FDA 510(k) clearance record for PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399, a class I device, cleared for Premium Plus International Limited on under FDA product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental). FDA records list 4 510(k) clearances for Premium Plus International Limited, from to . As of , FDA records show no recalls naming K100854.

Clearance record

Decision date
Received
(258 days to decision)
Product code
EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Premium Plus International Limited 33 Wang Yip St. W., Hong Kong, CN
510(k) summary
Statement
Third party review
No

Clearances, product code EGS

Trailing 12 months

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

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