510(k) K261695
- Device
- Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
- Applicant
- Guilin Kevin Peter Technology Co., Ltd.
- 510(k) number
- K261695
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-31
- Date received
- 2026-05-22
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Qian Zhang
- Address
- North Side Of Linsu Rd., Lingui Town, Lingui Dist. Guilin CN 541100 541100
FDA Registration Numbers#
- 3008582406
- 9613375
- 1013257
- 8030452
- 9610902
- 3027526455
- 3010127342
- 3014579161
- 3007584711
- 9680954
- 2241860
- 1718476
- 3010864832
- 3010419931
- 3009482106
- 3016447764
- 3010664129
- 1223843
- 3012354669
- 3009582362
- 1721647
- 2921595
- 1723973
- 3003637274
- 3007113445
- 3018047916
- 3005176727
- 8030067
- 3005665377
- 1450653
- 3014615644
- 3010131268
- 3045891668
- 3000219976
- 3004146043
- 3019596325
- 3002789526
- 3011221537
- 9681356
- 3018507299
- 9616128
- 3038718579
- 3008254125
- 3004491043
- 3005904906
- 2018957
- 3003449480
- 3005347791
- 1410097
- 1420052
- 3008578884
- 3015189878
- 3006542438
- 3024749697
- 3012477813
- 3011824442
- 3008494285
- 3013410675
- 2086043
- 3018283083
- 3045857207
- 2024980
- 3045816931
- 3001124136
- 3013934196
- 3009117991
- 3022516928
- 3008582054
- 9613953
- 3012421607
- 3011430871
- 2027375
- 3039359767
- 3015527825
- 2437780
- 8020994
- 3027494823
- 2081055
- 3008882689
- 3002808149
Source Documents#
Other 510(k) Records For Product Code EBF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 |