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Is Tip

by B&L Biotech 6 variants

Part of a family of 6 devices: see the family page

Model STS-5A, STS-5E

Is Tip is a dental implant/teeth debridement brush (EU MDR Class IIa; FDA Class I; FDA product code JET, Pick, Massaging) made by B&L Biotech, registered in EUDAMED on 29 May 2024 (Basic UDI-DI 88000191ISTIPMQ) and listed in FDA GUDID since 14 Oct 2022 (UDI-DI 08800019110446), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000191ISTIPMQ Basic UDI-DI 08800019110446UDI-DIDate29 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019110446 UDI-DI Date14 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000191ISTIPMQ registered 29 May 2024 Active
  • FDA GUDID UDI-DI 08800019110446 listed 14 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019110446
  2. Registered EUDAMED 88000191ISTIPMQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Dental implant/teeth debridement brush, biodegradable
Model / reference
STS-5A EUDAMED
STS-5E EUDAMED
STS5A5 GUDID
Primary DI / UDI-DI
08800019110446
Basic UDI-DI
88000191ISTIPMQ
FDA product code
JET
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Dental implant/teeth debridement brush, biodegradable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6650
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
STS-5A, STS-5E
none
GUDID
STS5A5
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000023296
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)