510(k) K181917
- Device
- MTA2.3 MATERIALS
- Applicant
- NuSmile, LTD.
- 510(k) number
- K181917
- Product code
- KIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-11
- Date received
- 2018-07-17
- Regulation
- 872.3820
- Classification name
- Resin, Root Canal Filling
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alafiz Prasla
- Address
- 3315 W. 12th St. Houston TX US 77008 77008
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#
Other 510(k) Records For Product Code KIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253167 | Any-Paste | Mediclus Co., Ltd. | 2026-01-12 |
| K252890 | ZenSeal Pro | Kerr Corporation | 2026-01-07 |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | 2025-09-25 |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 2025-09-19 |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025-08-22 |
| K251390 | MTA vpt | Voco GmbH | 2025-07-03 |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | 2025-06-11 |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025-03-14 |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | 2025-02-13 |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-12-12 |
| K242702 | VioSeal | Spident Co., Ltd. | 2024-11-07 |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-10-03 |
| K241457 | Vista BC Putty | Inter-Med, Inc. | 2024-08-28 |
| 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 |
Legacy Summary#
summary
FDA Review#
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