Spline® Twist™ Implant System
GUDID 00889024013001
ZIMMER DENTAL INC.
Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece| Primary Device ID | 00889024013001 |
| NIH Device Record Key | 5a3fe404-ae83-448e-b0d6-0dc1cd75de1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spline® Twist™ Implant System |
| Version Model Number | 1960 |
| Company DUNS | 103167086 |
| Company Name | ZIMMER DENTAL INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024013001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013494
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-21 |
On-Brand Devices [Spline® Twist™ Implant System]
| 00889024013315 | 2135 |
| 00889024013308 | 2133 |
| 00889024013292 | 2131 |
| 00889024013285 | 2130 |
| 00889024013278 | 2121 |
| 00889024013261 | 2120 |
| 00889024013193 | 1996 |
| 00889024013186 | 1995 |
| 00889024013179 | 1994 |
| 00889024013162 | 1993 |
| 00889024013155 | 1992 |
| 00889024013148 | 1991 |
| 00889024013131 | 1990 |
| 00889024013124 | 1989 |
| 00889024013117 | 1988 |
| 00889024013100 | 1987 |
| 00889024013094 | 1986 |
| 00889024013087 | 1985 |
| 00889024013070 | 1984 |
| 00889024013063 | 1983 |
| 00889024013056 | 1982 |
| 00889024013049 | 1981 |
| 00889024013032 | 1980 |
| 00889024013025 | 1979 |
| 00889024013018 | 1961 |
| 00889024013001 | 1960 |
Trademark Results [Spline]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPLINE 86812634 5152234 Live/Registered |
KAI U.S.A., Ltd. 2015-11-06 |
 SPLINE 86093919 4898978 Live/Registered |
ARISTA NETWORKS, INC. 2013-10-17 |
 SPLINE 79355710 not registered Live/Pending |
DT Swiss Deutschland GmbH 2022-08-23 |
 SPLINE 79114485 4359585 Live/Registered |
DT Swiss AG 2012-05-21 |
 SPLINE 75475816 2271901 Live/Registered |
ZIMMER DENTAL INC. 1998-04-28 |
 SPLINE 74615238 2099807 Dead/Cancelled |
MITSUBISHI ELECTRIC INFORMATION TECHNOLOGY CENTER AMERICA INC. 1994-12-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.