ZCORE™ EXPAND
GUDID D765ZXSOCKET101
Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm
Osteogenics Biomedical Inc
Dental bone matrix implant, animal-derived| Primary Device ID | D765ZXSOCKET101 |
| NIH Device Record Key | d7d917dc-4e5e-451d-bec5-251fe9a915ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZCORE™ EXPAND |
| Version Model Number | ZXSOCKET-10 |
| Company DUNS | 123853058 |
| Company Name | Osteogenics Biomedical 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 | false |
| 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 Dimensions
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
| Width | 5 Millimeter |
| Length | 17 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D765ZXSOCKET100 [Primary] |
| HIBCC | D765ZXSOCKET101 [Package] Contains: D765ZXSOCKET100 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202183
FDA Product Code
| NPM | Bone Grafting Material, Animal Source |
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 | 2025-04-22 |
| Device Publish Date | 2025-04-14 |
On-Brand Devices [ZCORE™ EXPAND]
| D765ZXSOCKET0 | Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm |
| D765ZXSINUSS0 | Expandable Collagen-Enriched Porcine Xenograft (Small Sinus), 10 mm x 13 mm |
| D765ZXSINUSL0 | Expandable Collagen-Enriched Porcine Xenograft (Large Sinus), 12 mm x 17 mm |
| D765ZXSOCKET51 | Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm |
| D765ZXSOCKET101 | Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm |
| D765ZXSOCKET10 | Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm |
Trademark Results [ZCORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZCORE 90382931 not registered Live/Pending |
Arch Wood Protection, Inc. 2020-12-15 |
 ZCORE 88610149 not registered Live/Pending |
ZO Skin Health, Inc. 2019-09-09 |
 ZCORE 86450363 5027746 Live/Registered |
TEK Group International 2014-11-11 |
 ZCORE 79277294 not registered Live/Pending |
HITACHI CONSTRUCTION MACHINERY CO., LTD. 2019-10-07 |
 ZCORE 78239197 2828031 Live/Registered |
O'Brien Dental Lab, Inc. 2003-04-17 |
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