Tubli-Seal Ewt
FDA 510(k) K942393 · Sybron Dental Specialties, Inc.
510(k) numberK942393
Submission
- Device name
- Tubli-Seal Ewt
- Applicant
- Sybron Dental Specialties, Inc.
Glendora, CA, US - Received
- May 19, 1994
- Decision date
- June 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | 07/27/2016SE |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTKIF · Traditional | 05/06/2016SE |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
| K151526 | Zone, ZoneFree, Zone A1EMA · Traditional | 09/10/2015SE |
| K151332 | Nexus Universal, Nexus Universal ChromaEMA · Abbreviated | 08/17/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | 06/19/2015SE |
| K143209 | SonicFill 2EBF · Traditional | 02/05/2015SE |
Questions and answers
When was Tubli-Seal Ewt cleared by the FDA?
Tubli-Seal Ewt (K942393) received a 510(k) decision of Substantially Equivalent on June 10, 1994, 22 days after the submission was received.
What is the product code of K942393?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.