Expasyl Power Applicator
FDA 510(k) K051933 · Sybron Dental Specialties, Inc.
510(k) numberK051933
Submission
- Device name
- Expasyl Power Applicator
- Applicant
- Sybron Dental Specialties, Inc.
Orange, CA, US - Received
- July 13, 2005
- Decision date
- January 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional | B&E Korea Co., Ltd. | 02/13/2024SE |
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| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
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| K160097 | Image Fast Set, Image Regular SetELW · Traditional | 08/05/2016SE |
| 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 Expasyl Power Applicator cleared by the FDA?
Expasyl Power Applicator (K051933) received a 510(k) decision of Substantially Equivalent on January 3, 2006, 174 days after the submission was received.
What is the product code of K051933?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.