Venus Pearl PLT Refill A1
FDA 510(k) K112501 · Heraeus Kulzer, LLC
510(k) numberK112501
Submission
- Device name
- Venus Pearl PLT Refill A1
- Applicant
- Heraeus Kulzer, LLC
South Bend, IN, US - Received
- August 30, 2011
- Decision date
- December 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | Ultradent Products, Inc. | 07/01/2026SE |
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| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
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| K123278 | Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch…KLE · Special | 12/07/2012SE |
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| K113574 | Flexitime Monophase Pro ScanELW · Traditional | 07/13/2012SE |
| 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 |
| K091635 | Venus Diamond FlowEBF · Abbreviated | 09/03/2009SE |
Questions and answers
When was Venus Pearl PLT Refill A1 cleared by the FDA?
Venus Pearl PLT Refill A1 (K112501) received a 510(k) decision of Substantially Equivalent on December 14, 2011, 106 days after the submission was received.
What is the product code of K112501?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.