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Trilor FDS10PP

by Bioloren SRL

Trilor FDS10PP is a Class II device made by Bioloren SRL, cleared under FDA 510(k) K173643 on 24 Feb 2018 and listed in FDA GUDID since 13 Sep 2021 (UDI-DI 08056099231988), 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) K173643

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 Number08056099231988 UDI-DI Date13 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK173643 Date24 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173643 decided 24 Feb 2018 Active
  • FDA GUDID UDI-DI 08056099231988 listed 13 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173643
  2. Listed FDA GUDID 08056099231988

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trilor
Generic name
Dental implant suprastructure, permanent, preformed
Model / reference
FDS10PP
Primary DI / UDI-DI
08056099231988
510(k) Number
FDA product code
EBF
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution
Size
Height — 10 Millimeter

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K173643)

and 8 more cleared under K173643

Similar devices in this category

Other devices filed under Dental implant suprastructure, permanent, preformed.

Other devices from Bioloren SRL

  • Trilor FDC20PP

    Class II

  • Trilor FDS16P

    Class II

  • Trilor FDC10

    Class II

  • Trilor FDC25

    Class II

See all devices from Bioloren SRL →

Properties

  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)