Futurabond Dc/Single Dose
FDA 510(k) K070723 · Voco GmbH
510(k) numberK070723
Submission
- Device name
- Futurabond Dc/Single Dose
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- March 15, 2007
- Decision date
- June 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | 05/01/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | 04/27/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | 03/20/2026SE |
| K251390 | MTA vptKIF · Traditional | 07/03/2025SE |
| K251239 | GrandioSO UnlimitedEBF · Special | 05/21/2025SE |
| K231817 | AlignerFlow LCDYH · Traditional | 12/01/2023SE |
| K231591 | V-Print c&b tempPOW · Traditional | 07/31/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | 07/13/2023SE |
| K220236 | V-Print dentbaseEBI · Traditional | 09/21/2022SE |
| K220640 | Bifix Hybrid Abutment CementEMA · Traditional | 08/23/2022SE |
Questions and answers
When was Futurabond Dc/Single Dose cleared by the FDA?
Futurabond Dc/Single Dose (K070723) received a 510(k) decision of Substantially Equivalent on June 7, 2007, 84 days after the submission was received.
What is the product code of K070723?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.