# Bl Tip

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/bl-tip-19110231>
- Manufacturer: [B&L Biotech](https://devicerts.com/manufacturers/bl-biotech) (South Korea)
- Name in the registry: BL TIP
- Device class: Class IIa (EU MDD / EU MDR); Class I (US FDA)
- FDA product code: JET
- EMDN: Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER
- GMDN: Ultrasonic dental scaling/debridement system handpiece tip, endodontic (46035)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI 88000191BLTIPHS · UDI-DI 08800019110231 · registered 2024-03-27 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 88000191BLTIPHS · UDI-DI 08800019110231 · registered 2024-03-27 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08800019110231 · listed 2022-10-14 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Generic name: Ultrasonic dental scaling/debridement system handpiece tip, endodontic [FDA GUDID (AccessGUDID)]
- Model / reference: BL-1-A [EUDAMED]; BL-1-E BL-3-A [EUDAMED]; BL-3-E BL-5-A [EUDAMED]; BL-5-E [EUDAMED]; BL-3-E [EUDAMED]; BL3E [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08800019110231 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 88000191BLTIPHS [EUDAMED]; B-08800019110231 [EUDAMED]
- FDA product code: JET [FDA GUDID (AccessGUDID)]
- EMDN code: Q010199 [EUDAMED]
- GMDN term: Ultrasonic dental scaling/debridement system handpiece tip, endodontic (46035) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 872.6650 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]; Legacy device (under a directive) [EUDAMED]
- EU market of registration: Poland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Bl Tip, B&L Biotech. deviCERTS medical device catalogue. https://devicerts.com/devices/bl-tip-19110231 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/bl-tip-19110231.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/bl-tip-19110231
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.