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Mectron Crown Prep Tip TA16D60 -Us

by Mectron SpA

Mectron Crown Prep Tip TA16D60 -Us (03590003-101) is a dental ultrasonic surgical system handpiece tip (FDA Class II) made by Mectron SpA, cleared under FDA 510(k) K151248 on 4 Sep 2015 and listed in FDA GUDID since 30 Aug 2016 (UDI-DI E322035900031010), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K151248

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE322035900031010 UDI-DI Date30 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151248 Date4 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151248 decided 4 Sep 2015 Active
  • FDA GUDID UDI-DI E322035900031010 listed 30 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151248
  2. Listed FDA GUDID E322035900031010

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mectron
Generic name
Dental ultrasonic surgical system handpiece tip
Model / Ref / Catalog
CROWN PREP TIP TA16D60 -US, 03590003-101
Primary DI / UDI-DI
E322035900031010
510(k) Number
FDA product code
ELC, DZI
GMDN term
Dental ultrasonic surgical system handpiece tip
Device class
Class II
Regulation number
872.4850, 872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Ultrasonic dental scaling/debridement system handpiece tip, periodontalDental ultrasonic surgical system handpiece tip

Cleared under the same submission (K151248)

and 8 more cleared under K151248

Similar devices

Other devices filed under FDA product code ELC (Scaler, Ultrasonic).

Other devices from Mectron SpA

  • Mectron OP1125

    Class II

  • Mectron OP1225

    Class II

  • Mectron EX0410

    Class II

  • Mectron EX0510

    Class II

See all devices from Mectron SpA →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)