BioHorizons MDL2015SZ
GUDID 00847236013905
MDL Implant Single Ossean 2.0 x 15mm
BIOHORIZONS IMPLANT SYSTEMS, INC
Screw endosteal dental implant, two-piece| Primary Device ID | 00847236013905 |
| NIH Device Record Key | eb462c68-9969-49e1-aca2-a49ac0ce43e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioHorizons |
| Version Model Number | MDL2015SZ |
| Catalog Number | MDL2015SZ |
| Company DUNS | 967279910 |
| Company Name | BIOHORIZONS IMPLANT SYSTEMS, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847236013905 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070601
FDA Product Code
| DZE | Implant, Endosseous, Root-Form |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-04 |
| Device Publish Date | 2021-12-27 |
On-Brand Devices [BioHorizons]
| 00847236014124 | Prosthetic Screw, Multi-unit, Small (pack of 5) |
| 00847236013691 | Multi-unit Direct Pick-up Coping |
| 00847236013653 | 3.0mm Deep Bone Profiler |
| 00847236013646 | 3.5mm Deep Bone Profiler |
| 00847236013639 | 4.5mm Deep Bone Profiler |
| 00847236013622 | 5.7mm Deep Bone Profiler |
| 00847236013615 | Prosthetic Screw, Multi-unit, Regular |
| 00847236013608 | 3.0mm Snap Scan Body, 8mm |
| 00847236013592 | 3.0mm Snap Scan Body, 11mm |
| 00847236013585 | 3.5mm Snap Scan Body, 8mm |
| 00847236013578 | 3.5mm Snap Scan Body, 11mm |
| 00847236013561 | 4.5mm Snap Scan Body, 8mm |
| 00847236013554 | 4.5mm Snap Scan Body, 11mm |
| 00847236013547 | 5.7mm Snap Scan Body, 8mm |
| 00847236013530 | 5.7mm Snap Scan Body, 11mm |
| 00847236013523 | 3.0mm Straight Contour Abutment (3mm buccal height) |
| 00847236013516 | 3.0mm Straight Contour Abutment |
| 00847236013509 | 3.0mm Dual Purpose Contour Abutment |
| 00847236013493 | 3.0mm Angled Contour Abutment |
| 00847236013486 | 3.5mm Straight Contour Abutment (3mm buccal height) |
| 00847236013479 | 3.5mm Straight Contour Abutment |
| 00847236013462 | 3.5mm Dual Purpose Contour Abutment |
| 00847236013455 | 3.5mm Angled Contour Abutment |
| 00847236013448 | 4.5mm Straight Contour Abutment (3mm buccal height) |
| 00847236013431 | 4.5mm Straight Contour Abutment |
| 00847236013424 | 4.5mm Dual Purpose Contour Abutment |
| 00847236013417 | 4.5mm Angled Contour Abutment |
| 00847236013400 | 5.7mm Straight Contour Abutment |
| 00847236013394 | 5.7mm Dual Purpose Contour Abutment |
| 00847236013387 | 5.7mm Angled Contour Abutment |
| 00847236013370 | 5.7mm Try-in Multi-unit Abutment, 30-degree |
| 00847236013363 | 5.7mm Try-in Multi-unit Abutment, 17-degree |
| 00847236013356 | Precision Angled Driver, 4mm Square, Extra Long |
| 00847236013349 | Precision Angled Driver, 4mm Square, Long |
| 00847236013332 | Precision Angled Driver, Manual, Long |
| 00847236013325 | Precision Angled Driver, Handpiece, Long |
| 00847236013318 | ODSecure Xtend Lab Process Insert (Black) (4 pack) |
| 00847236013288 | Single-stage 3.5mm Hybrid Abutment Base, Hexed |
| 00847236013271 | Single-stage 4.5mm Hybrid Abutment Base, Hexed |
| 00847236013264 | Single-stage 5.7mm Hybrid Abutment Base, Hexed |
| 00847236013240 | 3.0mm Hybrid Abutment Base, 2mm Collar Height |
| 00847236013233 | 3.5mm Hybrid Abutment Base, 2mm Collar Height |
| 00847236013226 | 4.5mm Hybrid Abutment Base, 2mm Collar Height |
| 00847236013219 | 5.7mm Hybrid Abutment Base, 2mm Collar Height |
| 00847236013202 | 5.7mm Multi-unit Abutment, 30-degree, 4mm Collar |
| 00847236013196 | 5.7mm Multi-unit Abutment, 30-degree, 3mm Collar |
| 00847236013189 | 5.7mm Multi-unit Abutment, 17-degree, 2.25mm Collar |
| 00847236013172 | Tapered Offset Site Dilator Kit |
| 00847236013165 | 3.5mm Hybridge XD Kit |
| 00847236013134 | Tack Driver Tip, Manual |
Trademark Results [BioHorizons]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOHORIZONS 76452693 2794090 Live/Registered |
Evollution IP Holdings, Inc. 2002-09-25 |
 BIOHORIZONS 76452692 2794089 Live/Registered |
Evoluution IP Holdings, Inc. 2002-09-25 |
 BIOHORIZONS 75975064 1998825 Dead/Cancelled |
BioHorizons, Inc. 1993-10-06 |
 BIOHORIZONS 74735451 not registered Dead/Abandoned |
BioHorizons, Inc. 1995-09-28 |
 BIOHORIZONS 74735450 2017329 Dead/Cancelled |
BioHorizons, Inc. 1995-09-28 |
 BIOHORIZONS 74734382 not registered Dead/Abandoned |
BioHorizons, Inc. 1995-09-26 |
 BIOHORIZONS 74734381 not registered Dead/Abandoned |
BioHorizons, Inc. 1995-09-26 |
 BIOHORIZONS 74734343 not registered Dead/Abandoned |
BioHorizons, Inc. 1995-09-26 |
 BIOHORIZONS 74734342 2017325 Dead/Cancelled |
BioHorizons, Inc. 1995-09-26 |
 BIOHORIZONS 74734341 2021912 Dead/Cancelled |
BioHorizons, Inc. 1995-09-26 |
 BIOHORIZONS 74444510 1893788 Dead/Cancelled |
BioHorizons, Inc. 1993-10-06 |
 BIOHORIZONS 74444509 not registered Dead/Abandoned |
BioHorizons, Inc. 1993-10-06 |
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