510(k) K251470
- Device
- ResiCem EX
- Applicant
- Shofu Dental Corporation
- 510(k) number
- K251470
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-11
- Date received
- 2025-05-13
- Regulation
- 872.3275
- Classification name
- Cement, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mauro Malzyner
- Address
- 1225 Stone Dr. San Marcos CA US 92078 92078
FDA Registration Numbers
- 3008912871
- 3006805063
- 3022296393
- 8030938
- 3007743883
- 9680144
- 9612300
- 3004727093
- 3006316962
- 3012627824
- 3011689956
- 3004569445
- 3006665149
- 3035693034
- 3003449480
- 3015128224
- 1044031
- 9680845
- 1215305
- 1013257
- 3016447764
- 3016505723
- 8020994
- 3018507299
- 3012187973
- 3004966444
- 9611385
- 1718912
- 8044164
- 3003775534
- 3030447506
- 3006367836
- 3011649314
- 2437780
- 8030419
- 3009496224
- 3010864832
- 3003487388
- 2916735
- 3004146043
- 1450653
- 3012477813
- 3014615644
- 1821514
- 1000272892
- 3017674095
- 3004140838
- 8044038
- 3015272949
- 9681210
- 3012421607
- 9610964
- 3011824442
- 2511556
- 3042244574
- 2523320
- 3032378317
- 1281412
- 2320721
- 3042272797
- 1410097
- 3014579161
- 3006113314
- 8021851
- 9681356
- 2280629
- 3031841433
- 2921595
- 1424442
- 3005628474
- 8010908
- 8010638
- 3010002722
- 2126683
- 9681254
- 1420052
- 1000492377
- 3002808149
- 3006694515
Source Documents
510(k) summary PDF not indicated by FDA
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| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024-04-02 |
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