Spline® Implant System
GUDID 00889024011694
ZIMMER DENTAL INC.
Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed 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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