Well-Root ST
FDA 510(k) K170950 · Vericom Co., Ltd.
510(k) numberK170950
Submission
- Device name
- Well-Root ST
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- March 31, 2017
- Decision date
- December 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K152615 | Vonflex SELW · Traditional | 11/03/2016SE |
| K152518 | Vonflex S PuttyELW · Traditional | 11/30/2015SE |
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Questions and answers
When was Well-Root ST cleared by the FDA?
Well-Root ST (K170950) received a 510(k) decision of Substantially Equivalent on December 20, 2017, 264 days after the submission was received.
What is the product code of K170950?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.