Point 4 Flowable 2
FDA 510(k) K013325 · Kerr Dental Materials Center
510(k) numberK013325
Submission
- Device name
- Point 4 Flowable 2
- Applicant
- Kerr Dental Materials Center
Orange, CA, US - Received
- October 5, 2001
- Decision date
- October 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| K020303 | XR Primer 2KLE · Traditional | 04/19/2002SE |
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| K020092 | TemphaseEBG · Traditional | 02/22/2002SE |
| K014027 | Optibond Solo Plus 4KLE · Traditional | 02/22/2002SE |
| K013375 | Belleglass HP Opaque 2EBF · Traditional | 10/29/2001SE |
| K011908 | Optibond Solo Plus 3EBC · Traditional | 09/06/2001SE |
| K000357 | Ez Connect ResinEBF · Traditional | 04/28/2000SE |
Questions and answers
When was Point 4 Flowable 2 cleared by the FDA?
Point 4 Flowable 2 (K013325) received a 510(k) decision of Substantially Equivalent on October 23, 2001, 18 days after the submission was received.
What is the product code of K013325?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.