SPK Sealant
FDA 510(k) K091632 · 3M Company
510(k) numberK091632
Submission
- Device name
- SPK Sealant
- Applicant
- 3M Company
St. Paul, MN, US - Received
- June 4, 2009
- Decision date
- September 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260819 | Any-Com SealEBC · Traditional | Mediclus Co., Ltd. | 05/01/2026SE |
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| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | Pulpdent Corporation | 01/05/2018SE |
| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
| K162598 | HAPI SealEBC · Traditional | Bisco, Inc. | 05/23/2017SE |
| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
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Questions and answers
When was SPK Sealant cleared by the FDA?
SPK Sealant (K091632) received a 510(k) decision of Substantially Equivalent on September 3, 2009, 91 days after the submission was received.
What is the product code of K091632?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.