510(k) K023976
- Device
- ACROSEAL ROOT CANAL OR APICAL SEALER
- Applicant
- Septodont S.A.S.
- 510(k) number
- K023976
- Product code
- KIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-30
- Date received
- 2002-11-27
- Regulation
- 872.3820
- Classification name
- Resin, Root Canal Filling
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE H MATELSKI
- Address
- 1050 Connecticut Ave., NW Washington DC US 20036 20036
FDA Registration Numbers#
- 3003449480
- 1410097
- 3013584861
- 9616142
- 3008912871
- 3031606505
- 8020994
- 3032312561
- 9610964
- 1032227
- 2416455
- 3005628474
- 8030938
- 3006113314
- 1000492377
- 1215305
- 3035983708
- 3004425647
- 3021971019
- 3008822460
- 2245654
- 3006313979
- 3009130085
- 8010908
- 8010629
- 3003120666
- 8010414
- 3012627824
- 3009560600
- 1413475
- 2320721
- 3005831677
- 3038718579
- 2429849
- 9615399
- 3026400121
- 8010468
- 8010638
- 2411797
- 9681210
- 3013557697
- 1000272892
- 2433629
- 3012322979
- 3006223010
- 3030405669
- 3016447764
- 1721647
- 9616128
- 3011824442
- 2183301
- 3006444232
- 3012187973
- 2133714
- 3012996495
- 3009133627
- 3006542438
- 8030962
- 3004443427
- 3012494290
- 3012477813
- 3012421607
- 2436986
- 1718912
- 2024312
- 3012354669
- 9681254
- 3002807757
- 3000219976
- 3027344570
Source Documents#
510(k) summary PDF not indicated by FDA
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| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | 2024-07-30 |
| K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd. | 2024-05-28 |