510(k) K112259
- Device
- NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
- Applicant
- NOBEL BIOCARE AB
- 510(k) number
- K112259
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-10-28
- Date received
- 2011-08-08
- Regulation
- 872.3630
- Classification name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HERBERT CRANE
- Address
- 22715 Savi Ranch Pkwy. Yorba Linda, CA US 92887 92887
FDA Registration Numbers#
- 2087259
- 3007842672
- 3005121682
- 3009201148
- 3009847764
- 3010160527
- 3035532394
- 3009325911
- 3012106319
- 3007362683
- 1054986
- 3007536957
- 3017980266
- 3018501314
- 3010393542
- 3004370612
- 8020776
- 3006017180
- 3003618527
- 3023265483
- 3030089802
- 2249649
- 3013547803
- 8031058
- 3029906226
- 3006110126
- 3003310824
- 3021630667
- 3003184527
- 3027494823
- 3031886796
- 3007521935
- 3031462380
- 9614705
- 3005998060
- 3001110146
- 3002808227
- 3013102320
- 1038806
- 3008088588
- 1222802
- 3013271380
- 3012481042
- 3012422693
- 9611992
- 3015620565
- 3005031178
- 3008252251
- 9680605
- 2245590
- 1410097
- 3004417597
- 3024185724
- 3031529635
- 3003394627
- 3005126636
- 3005115116
- 1000625496
- 1526534
- 3007366413
- 3009482100
- 3007740664
- 3004203816
- 9611993
- 3008910197
- 3003847101
- 3014270103
- 3013960456
- 3001082453
- 3005409899
- 3015775866
- 3033519161
- 9617542
- 1222315
- 3004638532
- 3008261720
- 3036779616
- 3006411780
- 3008309654
- 3030426160
Source Documents#
Other 510(k) Records For Product Code NHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | 2026-09-23 |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | 2026-09-21 |
| 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 |
Legacy Summary#
summary
FDA Review#
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