510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K973062Substantially Equivalent

Twist Reciprocating Disposable Prophy Angle

Medidenta Intl., Inc., Woodside NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973062 is the FDA 510(k) clearance record for TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE, a class I device, cleared for Medidenta Intl., Inc. on under FDA product code EFA (Handpiece, Belt And/Or Gear Driven, Dental). FDA records list one 510(k) clearance for Medidenta Intl., Inc. As of , FDA records show no recalls naming K973062.

Clearance record

Decision date
Received
(52 days to decision)
Product code
EFA Handpiece, Belt And/Or Gear Driven, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Medidenta Intl., Inc. 39-23 62nd St., Woodside NY
510(k) summary
Statement
Third party review
No

Clearances, product code EFA

Trailing 12 months

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

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