Cuttersil Activator Universal Plus
FDA 510(k) K080338 · Heraeus Kulzer,GmbH
510(k) numberK080338
Submission
- Device name
- Cuttersil Activator Universal Plus
- Applicant
- Heraeus Kulzer,GmbH
South Bend, IN, US - Received
- February 7, 2008
- Decision date
- April 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K213175 | No Stress ImpressELW · Traditional | No Stress Impress, LLC | 01/19/2023SE |
| 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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| 510(k) | Device | Decision |
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| K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLELW · Traditional | 05/17/2013SE |
| K123278 | Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch…KLE · Special | 12/07/2012SE |
| K120914 | Flexitime Fast & Scan Light FlowELW · Special | 07/25/2012SE |
| K113574 | Flexitime Monophase Pro ScanELW · Traditional | 07/13/2012SE |
| K112501 | Venus Pearl PLT Refill A1EBF · Traditional | 12/14/2011SE |
| K111832 | Paladon Ultra Powder (Pink), Paladon Ultra LiquidEBI · Traditional | 09/29/2011SE |
| K110037 | Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidEBI · Traditional | 04/29/2011SE |
| K102770 | Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium…ELW · Traditional | 12/21/2010SE |
| K101617 | Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…ELW · Traditional | 09/07/2010SE |
| K093575 | Gluma Desensitizer Power GelLBH · Traditional | 03/05/2010SE |
Questions and answers
When was Cuttersil Activator Universal Plus cleared by the FDA?
Cuttersil Activator Universal Plus (K080338) received a 510(k) decision of Substantially Equivalent on April 21, 2008, 74 days after the submission was received.
What is the product code of K080338?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.