# Kimtrac

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

- Canonical page: <https://devicerts.com/devices/kimtrac-19111153>
- Manufacturer: [B&L Biotech](https://devicerts.com/manufacturers/bl-biotech) (South Korea)
- Name in the registry: KIMTRAC
- Device class: Class I (EU MDD / EU MDR / US FDA)
- FDA product code: NDP
- EMDN: L150201 DENTAL RETRACTORS, REUSABLE
- GMDN: Periosteal elevator, reusable (38168)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI 88000191KIMTRACNX · UDI-DI 08800019111153 · registered 2024-04-13 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 88000191KIMTRACNX · UDI-DI 08800019111153 · registered 2024-04-13 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08800019111153 · listed 2022-10-28 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Generic name: Periosteal elevator, reusable [FDA GUDID (AccessGUDID)]
- Model / reference: KTR-M1S [EUDAMED]; KTR-M2S [EUDAMED]; KTR-M3S [EUDAMED]; KTR-M4S [EUDAMED]; KTR-M5S [EUDAMED]; KTR-P1S [EUDAMED]; KTR-P2S [EUDAMED]; KTR-M1N [EUDAMED]; KTR-M2N [EUDAMED]; KTR-M3N [EUDAMED]; KTR-M4N [EUDAMED]; KTR-M5N [EUDAMED]; KTR-P1N [EUDAMED]; KTR-P2N [EUDAMED]; KTN1S [EUDAMED]; KTN2S [EUDAMED]; KTN3S [EUDAMED]; KTN4S [EUDAMED]; KTNNH [EUDAMED]; KTN1N [EUDAMED]; KTN2N [EUDAMED, FDA GUDID (AccessGUDID)]; KTN3N [EUDAMED]; KTN4N [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08800019111153 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 88000191KIMTRACNX [EUDAMED]; B-08800019111153 [EUDAMED]
- FDA product code: NDP [FDA GUDID (AccessGUDID)]
- EMDN code: L150201 [EUDAMED]
- GMDN term: Periosteal elevator, reusable (38168) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED, FDA GUDID (AccessGUDID)]
- Regulation number: 872.3980 [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)]
- Reusable: Yes [EUDAMED]
- 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)]
- 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: Kimtrac, B&L Biotech. deviCERTS medical device catalogue. https://devicerts.com/devices/kimtrac-19111153 (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/kimtrac-19111153.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/kimtrac-19111153
- 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.