LC Composite
FDA 510(k) K991492 · Harry J. Bosworth Co.
510(k) numberK991492
Submission
- Device name
- LC Composite
- Applicant
- Harry J. Bosworth Co.
Skokie, IL, US - Received
- April 28, 1999
- Decision date
- December 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251389 | High speed air turbine handpieceEFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | W&H Dentalwerk Bürmoos GmbH | 02/28/2025SE |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 11/13/2024SE |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | Nakanishi, Inc. | 09/20/2024SE |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional | Litu Tech , Ltd. | 04/30/2024SE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | Nakanishi, Inc. | 04/25/2024SE |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
| K232243 | EVO 700 series high speed handpieceEFB · Special | Ttbio Corp. | 08/23/2023SE |
More from Ttbio Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K103585 | Bosworth Aegis Liner & Restorative Material W/AcpEMA · Traditional | 03/04/2011SE |
| K100731 | Bosworth Air PolisherEFB · Traditional | 12/03/2010SE |
| K061611 | Bosworth Dentin ResinKLE · Traditional | 09/11/2006SE |
| K051224 | Bosworth SealEBC · Traditional | 07/28/2005SE |
| K043170 | Bosworth BondKLE · Traditional | 02/25/2005SE |
| K040548 | Aegis Ortho Light-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K040547 | Aegis Ortho Dual-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K033751 | Aegis Pit & Fissure Sealant with AcpEBC · Traditional | 02/05/2004SE |
| K031439 | Alginate Impression Material III (Fast & Regular)ELW · Traditional | 10/02/2003SE |
| K031811 | Pit & Fissure Sealant with FluorideEBC · Traditional | 09/04/2003SE |
Questions and answers
When was LC Composite cleared by the FDA?
LC Composite (K991492) received a 510(k) decision of Substantially Equivalent on December 2, 1999, 218 days after the submission was received.
What is the product code of K991492?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.