Spline®
GUDID 00889024012615
ZIMMER DENTAL INC.
Dental implant suprastructure, temporary, preformed, single-use| Primary Device ID | 00889024012615 |
| NIH Device Record Key | 5638b9a5-732d-445b-8869-aed2d2210561 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spline® |
| Version Model Number | 1807 |
| 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 | 00889024012615 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K001786
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
[00889024012615]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-07 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Spline®]
| 00889024013360 | 2180 |
| 00889024013339 | 2176 |
| 00889024012134 | 1620 |
| 00889024012127 | 1619 |
| 00889024012110 | 1618 |
| 00889024012011 | 1588 |
| 00889024012004 | 1587 |
| 00889024011724 | 1504 |
| 00889024011717 | 1503 |
| 00889024011700 | 1502 |
| 00889024011298 | 0769 |
| 00889024011281 | 0768 |
| 00889024011274 | 0767 |
| 00889024013544 | 2730 |
| 00889024013537 | 2728 |
| 00889024013520 | 2719 |
| 00889024013513 | 2715 |
| 00889024013445 | 2302 |
| 00889024011601 | 1214 |
| 00889024011557 | 1209 |
| 00889024011526 | 1206 |
| 00889024011366 | 0816 |
| 00889024013490 | 2406 |
| 00889024013483 | 2405 |
| 00889024013476 | 2404 |
| 00889024013469 | 2403 |
| 00889024013384 | 2184 |
| 00889024013377 | 2182 |
| 00889024012486 | 1694 |
| 00889024010970 | 0541 |
| 00889024010963 | 0540 |
| 00889024013391 | 2220 |
| 00889024013551 | 2740 |
| 00889024013254 | 2052 |
| 00889024013247 | 2051 |
| 00889024013230 | 2050 |
| 00889024012998 | 1951 |
| 00889024012981 | 1950 |
| 00889024012974 | 1949 |
| 00889024012967 | 1947 |
| 00889024012950 | 1946 |
| 00889024012943 | 1945 |
| 00889024012936 | 1943 |
| 00889024012929 | 1942 |
| 00889024012912 | 1941 |
| 00889024012905 | 1939 |
| 00889024012868 | 1839 |
| 00889024012851 | 1837 |
| 00889024012844 | 1836 |
| 00889024012837 | 1834 |
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.