Splash! Impression Material Device
FDA 510(k) K052090 · Discus Dental, Inc.
510(k) numberK052090
Submission
- Device name
- Splash! Impression Material Device
- Applicant
- Discus Dental, Inc.
Culver City, CA, US - Received
- August 2, 2005
- Decision date
- August 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K092417 | Insight Ultrasonic InsertsELC · Traditional | 12/11/2009SE |
| K073518 | Flashlite Rebel*EBZ · Traditional | 12/20/2007SE |
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| K051776 | Protege Ultrasonic InsertELC · Traditional | 07/13/2005SE |
| K033785 | Proactive Care Prophylaxis Paste with FluorideEJR · Traditional | 06/18/2004SE |
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Questions and answers
When was Splash! Impression Material Device cleared by the FDA?
Splash! Impression Material Device (K052090) received a 510(k) decision of Substantially Equivalent on August 5, 2005, 3 days after the submission was received.
What is the product code of K052090?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.