All-Bound 3
FDA 510(k) K102844 · Bisco, Inc.
510(k) numberK102844
Submission
- Device name
- All-Bound 3
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- September 29, 2010
- Decision date
- October 29, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
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Questions and answers
When was All-Bound 3 cleared by the FDA?
All-Bound 3 (K102844) received a 510(k) decision of Substantially Equivalent on October 29, 2010, 30 days after the submission was received.
What is the product code of K102844?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.