Spline® Implant System
GUDID 00889024011694
ZIMMER DENTAL INC.
Dental implant suprastructure, permanent, preformed| Primary Device ID | 00889024011694 |
| NIH Device Record Key | f95d5b26-fbc2-4f7d-af51-8d904ce59833 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spline® Implant System |
| Version Model Number | 1501 |
| 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 | false |
| 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 | 00889024011694 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K944327
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
[00889024011694]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-10-23 |
Devices Manufactured by ZIMMER DENTAL INC.
| 00889024017788 - Driva | 2023-07-17 STEP DRILL,3.8/3.4MM,25MM |
| 00889024015890 - Tapered SwissPlus® & SwisPlus® | 2023-06-29 |
| 00889024015630 - N/A | 2021-03-10 |
| 00889024010949 - Tapered Screw-Vent® Screw-Vent® AdVent® Tapered SwissPlus® Spline® | 2020-03-23 |
| 00889024010956 - Integral® | 2020-03-23 |
| 00889024010963 - Spline® | 2020-03-23 |
| 00889024010970 - Spline® | 2020-03-23 |
| 00889024011496 - N/A | 2020-03-23 |
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 |
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