510(k) K251578
- Device
- BEAUTIFIL II
- Applicant
- Shofu Dental Corporation
- 510(k) number
- K251578
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-27
- Date received
- 2025-05-22
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- Y
Related Records
Applicant Contact
- Contact
- Malzyner Mauro
- Address
- 1225 Stone Dr. San Marcos CA US 92078 92078
FDA Registration Numbers
- 3002789526
- 3005176727
- 1410097
- 3013584861
- 3003114027
- 9612352
- 3006316962
- 3012312751
- 2916735
- 1281412
- 3039433962
- 3017674095
- 1420052
- 3015978392
- 3012389497
- 1420089
- 3031841433
- 3030515618
- 3019596325
- 9681356
- 2241860
- 2086043
- 3009117991
- 3007791519
- 3013557697
- 2433629
- 3005347791
- 9680954
- 3032378317
- 3009482106
- 3006694515
- 3012187973
- 8030452
- 8030067
- 1424442
- 3005665377
- 3012354669
- 8044038
- 3012441963
- 9613953
- 3003637274
- 3002807050
- 3003449480
- 3008912871
- 3000268902
- 3024749697
- 3032312561
- 3006291983
- 8030938
- 1215305
- 1937100
- 3015302693
- 3010131268
- 1221541
- 3004967419
- 3022296393
- 8010908
- 2511556
- 2027375
- 3012627824
- 1000118628
- 2424472
- 1718476
- 3003621174
- 3008582406
- 2024980
- 3038718579
- 9615399
- 3026400121
- 3027616
- 2411797
- 9681210
- 3024185724
- 3010419931
- 3007113445
- 1000272892
- 3010864832
- 3032027578
- 3026312357
Source Documents
510(k) summary PDF not indicated by FDA
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