510(k) K232271
- Device
- SIMDA abutment
- Applicant
- Simda Co., Ltd.
- 510(k) number
- K232271
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-26
- Date received
- 2023-07-31
- Regulation
- 872.3630
- Classification name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cha Young Woo
- Address
- 156-4, Gamjeon-Dong Busan KR
FDA Registration Numbers#
- 3011936113
- 3004748290
- 3001082453
- 2245590
- 3004201263
- 3013111692
- 2029275
- 3038715999
- 1531062
- 2032098
- 3013551048
- 3007518363
- 3006592743
- 3008517893
- 3015775866
- 8020776
- 9613283
- 9611993
- 3004883837
- 3011587077
- 3019252621
- 3014270094
- 3015160953
- 1424785
- 3039641923
- 3031462380
- 3038549074
- 2024024
- 3008088588
- 3014596751
- 3027595870
- 3011656326
- 9680605
- 8010591
- 3013950969
- 9611992
- 1222315
- 3012205930
- 3004884150
- 1000625496
- 2921595
- 3013465593
- 3005674514
- 3024859204
- 3009528826
- 3035532394
- 3009611645
- 3011187779
- 2183744
- 2530808
- 8043971
- 3008102042
- 3013167159
- 1423662
- 8044131
- 3010251542
- 3009727738
- 3009761487
- 3005739655
- 3009840806
- 3006540014
- 3007740664
- 3001295407
- 3012422333
- 3008409772
- 3013960456
- 1036836
- 9617542
- 3001617766
- 3010178296
- 3026365523
- 3003394081
- 3021076825
- 3005121682
- 3015456817
- 3007126709
- 3042971970
- 3008261720
- 3033708818
- 3000279043
Source Documents#
Other 510(k) Records For Product Code NHA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | 2026-08-06 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | 2026-06-27 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026-06-11 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026-05-14 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026-05-07 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-04-16 |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026-04-09 |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | 2026-02-10 |