Mta Advanced Material
FDA 510(k) K073218 · Dentsply Interntional
510(k) numberK073218
Submission
- Device name
- Mta Advanced Material
- Applicant
- Dentsply Interntional
York, PA, US - Received
- November 15, 2007
- Decision date
- January 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261415 | Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 06/29/2026SE |
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| K252890 | ZenSeal ProKIF · Traditional | Kerr Corporation | 01/07/2026SE |
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| K251884 | One-Fil Putty InjectableKIF · Special | Mediclus Co., Ltd. | 08/22/2025SE |
| K251390 | MTA vptKIF · Traditional | Voco GmbH | 07/03/2025SE |
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| K080311 | Modified Temprx Esthetic Provisional SystemEBG · Traditional | 04/18/2008SE |
| K080246 | Composite Aligner ButtonNXC · Traditional | 04/11/2008SE |
| K080203 | Mta Root Canal SealerKIF · Traditional | 03/26/2008SE |
| K073173 | Self-Adhesive Resin CementEMA · Traditional | 01/23/2008SE |
Questions and answers
When was Mta Advanced Material cleared by the FDA?
Mta Advanced Material (K073218) received a 510(k) decision of Substantially Equivalent on January 7, 2008, 53 days after the submission was received.
What is the product code of K073218?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.