Primary Device ID | 07392532201608 |
NIH Device Record Key | a932e91c-5329-4ed7-a43a-50b8abbbbc85 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SIMPLANT® |
Version Model Number | 54500115 |
Catalog Number | 54500115 |
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 | false |
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 | 07392532201608 [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 | 2023-10-19 |
Device Publish Date | 2023-10-11 |
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 |