Surpass
FDA 510(k) K061981 · Apex Dental Materials, Inc.
510(k) numberK061981
Submission
- Device name
- Surpass
- Applicant
- Apex Dental Materials, Inc.
Deer Park, IL, US - Received
- July 13, 2006
- Decision date
- July 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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More from Rizhao Huge Biomaterials Company, Ltd.
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| K190998 | BA Pit & Fissure SealantEBC · Abbreviated | 11/08/2019SE |
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| K131049 | ZRPKLE · Traditional | 08/27/2013SE |
| K120620 | Clean and BoostKLE · Traditional | 05/31/2012SE |
| K110859 | Metal OpaquerEBF · Traditional | 06/23/2011SE |
| K092539 | SeamfreeEBF · Traditional | 10/01/2009SE |
| K091647 | InjectafilEBF · Traditional | 09/21/2009SE |
| K062157 | ConformEBF · Traditional | 10/13/2006SE |
| K053103 | InterfaceKLE · Abbreviated | 02/01/2006SE |
Questions and answers
When was Surpass cleared by the FDA?
Surpass (K061981) received a 510(k) decision of Substantially Equivalent on July 31, 2006, 18 days after the submission was received.
What is the product code of K061981?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.