Snowpost, Snowlight
FDA 510(k) K012354 · Danville Materials, Inc.
510(k) numberK012354
Submission
- Device name
- Snowpost, Snowlight
- Applicant
- Danville Materials, Inc.
San Ramon, CA, US - Received
- July 25, 2001
- Decision date
- October 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060075 | Fiber-Metal PostELR · Traditional | Foremost Dental, LLC | 03/30/2006SE |
| K042848 | FRC Postec PlusELR · Traditional | Ivoclar Vivadent, Inc. | 11/22/2004SE |
| K030820 | Everstick PostELR · Traditional | Stick Tech , Ltd. | 05/20/2003SE |
| K020431 | FibiocoreELR · Traditional | Est. Anthogyr | 07/03/2002SE |
| K012496 | Carbon PostELR · Traditional | J. Morita USA, Inc. | 05/17/2002SE |
| K013802 | FRC PostecELR · Traditional | Ivoclar Vivadent, Inc. | 05/01/2002SE |
| K012849 | Glass PostELR · Traditional | J. Morita USA, Inc. | 03/27/2002SE |
| K003221 | Harald Nordin Glassix Glass Fiber Composite Dental PostELR · Special | Harald Nordin S.A | 10/25/2000SE |
| K003219 | Harald Nordin Carbonite Carbon Fiber Composite Dental PostELR · Special | Harald Nordin S.A | 10/25/2000SE |
| K993545 | Tenax White PostELR · Traditional | Coltene/Whaledent, Inc. | 04/14/2000SE |
More from Coltene/Whaledent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152349 | Star+ VPS Scannable Impression MaterialELW · Traditional | 11/23/2015SE |
| K151514 | PrestigeEBF · Traditional | 09/21/2015SE |
| K151088 | DMRC Bulk FillEBF · Traditional | 08/28/2015SE |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and PrimerDYH · Traditional | 03/18/2015SE |
| K142881 | DMRC Dual Cure Orthodontic Band CementDYH · Traditional | 02/13/2015SE |
| K121880 | DMRC Nanoflow DMRC Nanocomposite Ebond Sure Etch Gel Sure Etch LiquidEBF · Traditional | 09/25/2012SE |
| K111876 | Z Bond, Prelude OneKLE · Traditional | 09/21/2011SE |
| K110642 | Siljetr SystemEBF · Traditional | 05/27/2011SE |
| K102753 | Turbo Temp 3EBG · Traditional | 02/04/2011SE |
| K092912 | Starfill 2B HV (High Viscosity) Rockcore, Model: 90838 and Starfill 2B LV (Low…EBF · Traditional | 12/16/2009SE |
Questions and answers
When was Snowpost, Snowlight cleared by the FDA?
Snowpost, Snowlight (K012354) received a 510(k) decision of Substantially Equivalent on October 10, 2001, 77 days after the submission was received.
What is the product code of K012354?
The FDA product code is ELR – Post, Root Canal, a Class I (low risk) device regulated under 21 CFR 872.3810.