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Soleil 123SS

by Premium Plus International Limited

Soleil 123SS is an instrument/equipment drape (FDA Class II; FDA product code PEM, Dental Barriers And Sleeves) made by Premium Plus International Limited, cleared under FDA 510(k) K163447 on 20 Jun 2017 and listed in FDA GUDID since 12 Jul 2017 (UDI-DI D838BC123SS2), active as of 22 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 22 Oct 2026

Documents

510(k) K163447

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD838BC123SS2 UDI-DI Date12 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163447 Date20 Jun 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163447 decided 20 Jun 2017 Active
  • FDA GUDID UDI-DI D838BC123SS2 listed 12 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163447
  2. Listed FDA GUDID D838BC123SS2

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Soleil
Generic name
Instrument/equipment drape, single-use, non-sterile
Model / reference
123SS
Primary DI / UDI-DI
D838BC123SS2
510(k) Number
FDA product code
PEM
GMDN term
Instrument/equipment drape, single-use, non-sterile
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Instrument/equipment drape, single-use, non-sterile

Cleared under the same submission (K163447)

and 8 more cleared under K163447

Similar devices

Other devices filed under FDA product code PEM (Dental Barriers And Sleeves).

Other devices from Premium Plus International Limited

See all devices from Premium Plus International Limited →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)