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Instrument PI starter kit FS-295#

by E.M.S. Electro Medical Systems S.A. 3 variants

Instrument PI starter kit FS-295# (FS-295#C) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K190124 on 20 Oct 2019 (1 earlier submission) and listed in FDA GUDID since 14 Jul 2026 (UDI-DI 07613353311803), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613353311803 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190124 Date20 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190124 decided 20 Oct 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07613353311803 listed 14 Jul 2026 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1686-2024 FDA Class II initiated 13 Mar 2024
    • Ongoing Z-1687-2024 FDA Class II initiated 13 Mar 2024
    • Ongoing Z-1688-2024 FDA Class II initiated 13 Mar 2024

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Timeline

6 dated events

  1. Cleared FDA 510(k) K132445
  2. Cleared FDA 510(k) K190124
  3. Recall initiated FDA recalls Z-1686-2024
  4. Recall initiated FDA recalls Z-1687-2024
  5. Recall initiated FDA recalls Z-1688-2024
  6. Listed FDA GUDID 07613353311803

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Instrument PI starter kit
Generic name
Ultrasonic dental scaling/debridement system
Model / Ref / Catalog
FS-295#, FS-295#C
Primary DI / UDI-DI
07613353311803
510(k) Number
FDA product code
ELC
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class II
Regulation number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K132445)

and 8 more cleared under K132445

Cleared under the same submission (K190124)

and 8 more cleared under K190124

Other devices from Electro Medical Systems (Ems Sa)

See all devices from Electro Medical Systems (Ems Sa) →

Properties

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