| Primary Device ID | 07392532213274 |
| NIH Device Record Key | 560604d2-404c-46b0-b3ff-a8a93e760654 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLANT® |
| Version Model Number | 31830737 |
| Catalog Number | 31830737 |
| Company DUNS | 344038836 |
| Company Name | Dentsply Implants Manufacturing GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07392532213274 [Primary] |
| NDP | Accessories, implant, dental, endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-25 |
| Device Publish Date | 2023-07-17 |
| 07392532269738 | O/Guide Sleeve 4.5 ND OmniTaper |
| 07392532269721 | C/Guide Sleeve 4.5 ND OmniTaper |
| 07392532269714 | C/Guide Sleeve 5.2 WD PrimeTaper/OmniTaper/AstraTech Impl EV |
| 07392532269707 | O/Guide Sleeve 5.2 WD PrimeTaper/OmniTaper/AstraTech Impl EV |
| 07392532269691 | C/Guide Sleeve 4.6 ND PrimeTaper/AstraTech Implant EV |
| 07392532269684 | O/Guide Sleeve 4.6 ND PrimeTaper/AstraTech Implant EV |
| 07392532254666 | Simplant Guide-Sleeve WP 3i |
| 07392532254659 | Simplant Guide-Sleeve RP 3i |
| 07392532254642 | Simplant Guide-Sleeve Ø6.3 BB |
| 07392532254635 | Simplant Guide-Sleeve Ø5.1 BG |
| 07392532254628 | Simplant Guide-Sleeve Ø4.3 BY |
| 07392532254611 | Simplant Guide-Sleeve Ø5.3 Z |
| 07392532254604 | Simplant Guide-Sleeve Ø4.2 Z |
| 07392532254598 | Simplant Guide-Sleeve Ø3.3 CG |
| 07392532254574 | Simplant Guide-Sleeve Ø4.3 CP |
| 07392532254567 | Simplant Guide-Sleeve Ø3.8 CY |
| 07392532213403 | C/Guide-Sleeve Ø2.1 |
| 07392532213397 | O/Guide-Sleeve Ø5.2 |
| 07392532213380 | O/Guide-Sleeve Ø4.2 |
| 07392532213373 | C/Guide-Sleeve Ø5.2 |
| 07392532213366 | C/Guide-Sleeve Ø4.2 |
| 07392532213359 | C/Guide-Sleeve Ø6.2 N |
| 07392532213342 | C/Guide-Sleeve Ø5.0 N |
| 07392532213335 | C/Guide-Sleeve Ø4.2 N |
| 07392532213328 | C/Guide-Sleeve Ø2.0 |
| 07392532213311 | C/Guide-Sleeve Ø5.0 S |
| 07392532213304 | Xive® C/Guide-Sleeve Ø5.2 WD |
| 07392532213281 | Xive® O/Guide-Sleeve Ø5.2 WD |
| 07392532213274 | Xive® C/Guide-Sleeve Ø4.5 ND |
| 07392532213267 | Xive® O/Guide-Sleeve Ø4.5 ND |
| 07392532213250 | EV C/Guide-Sleeve Ø5.2 WD |
| 07392532213243 | EV O/Guide-Sleeve Ø5.2 WD |
| 07392532213236 | EV C/Guide-Sleeve Ø4.6 ND |
| 07392532213229 | EV O/Guide-Sleeve Ø4.6 ND |
| 07392532213212 | Ankylos® C/Guide-Sleeve Ø4.9 WD |
| 07392532213205 | Ankylos® O/Guide-Sleeve Ø4.9 WD |
| 07392532213199 | Ankylos® C/Guide-Sleeve Ø4.5 ND |
| 07392532213182 | Ankylos® O/Guide-Sleeve Ø4.5 ND |
| 07392532244162 | Simplant Guide Titanium 02 imp |
| 07392532244155 | Simplant Guide Titanium 01 imp |
| 07392532201752 | LongStop Drill-L:28mm-D:3.15mm |
| 07392532201745 | LongStop Drill-L:28mm-D:2.75mm |
| 07392532201738 | LongStop Drill-L:28mm-D:1.95mm |
| 07392532201721 | LongStop Drill-L:25mm-D:3.15mm |
| 07392532201714 | LongStop Drill-L:25mm-D:1.95mm |
| 07392532201707 | LongStop Drill-L:25mm-D:2.75mm |
| 07392532201691 | LongStop Drill-L:23mm-D:2.75mm |
| 07392532201684 | LongStop Drill-L:23mm-D:1.95mm |
| 07392532201677 | LongStop Drill-L:23mm-D:3.15mm |
| 07392532201660 | LongStop Drill-L:20mm-D:3.15mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SIMPLANT 79016792 3171725 Live/Registered |
DENTSPLY Implants NV 2004-10-27 |
![]() SIMPLANT 77848515 3877954 Dead/Cancelled |
WomanCare Global LLC 2009-10-14 |