Bosworth Dentin Resin
FDA 510(k) K061611 · Harry J. Bosworth Co.
510(k) numberK061611
Submission
- Device name
- Bosworth Dentin Resin
- Applicant
- Harry J. Bosworth Co.
Skokie, IL, US - Received
- June 9, 2006
- Decision date
- September 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Rizhao Huge Biomaterials Company, Ltd.
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|---|---|---|
| K103585 | Bosworth Aegis Liner & Restorative Material W/AcpEMA · Traditional | 03/04/2011SE |
| K100731 | Bosworth Air PolisherEFB · Traditional | 12/03/2010SE |
| 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 |
| K994027 | Activator PasteELW · Traditional | 04/13/2000SE |
Questions and answers
When was Bosworth Dentin Resin cleared by the FDA?
Bosworth Dentin Resin (K061611) received a 510(k) decision of Substantially Equivalent on September 11, 2006, 94 days after the submission was received.
What is the product code of K061611?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.