510(k) K212664
- Device
- Sherlock
- Applicant
- Open Implants, LLC
- 510(k) number
- K212664
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-30
- Date received
- 2021-08-23
- 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
- Gregg Gellman
- Address
- 800 W. Cummngs Ave., Suite 4900 Woburn MA US 01801 01801
FDA Registration Numbers#
- 3008388248
- 3039397999
- 3007515069
- 3005115116
- 3009611645
- 3015978392
- 3003847101
- 3009161350
- 3043585140
- 9611993
- 3013465593
- 3017064961
- 3010287737
- 3013527433
- 3010251542
- 3012187973
- 3007740664
- 3009196578
- 3015194291
- 3042227762
- 3009514134
- 2436986
- 3011936113
- 3002807050
- 3017980266
- 3017833095
- 3009756327
- 3013111980
- 1220477
- 3009528809
- 3010160527
- 3019793783
- 3016733895
- 1060818
- 3007366413
- 3015218457
- 3009646999
- 3008494722
- 3024185724
- 3007842672
- 3013578168
- 3032802037
- 1036836
- 3004201263
- 3007728094
- 3004730368
- 1222315
- 8043971
- 3038715999
- 3010596333
- 9680605
- 3005031178
- 1054986
- 3010948854
- 3011545243
- 3002807310
- 3008309654
- 3009217531
- 1424263
- 3008102042
- 9617542
- 3009632672
- 2245590
- 3008793310
- 3006411780
- 3014329459
- 3007518363
- 1222802
- 2032098
- 2921595
- 3005554774
- 3008261720
- 1531062
- 3013271380
- 3014270103
- 3009432160
- 3035532393
- 3008812251
- 3006948193
Source Documents#
Other 510(k) Records For Product Code NHA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 |