Paltop 20-70007P
GUDID 07290108695816
Advanced + Dental Implant Ø4.2mm L10mm
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Screw endosteal dental implant, two-piece| Primary Device ID | 07290108695816 |
| NIH Device Record Key | c9cf3c82-c583-4dfd-92f6-d15041d048d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paltop |
| Version Model Number | 20-70007P |
| Catalog Number | 20-70007P |
| Company DUNS | 533836024 |
| Company Name | PALTOP ADVANCED DENTAL SOLUTIONS LTD |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290108695816 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112795
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-10 |
| Device Publish Date | 2021-03-02 |
On-Brand Devices [Paltop]
| 07290108694925 | Conical 5mm Straight Healing Cap |
| 07290108694918 | Conical 3mm Straight Healing Cap |
| 07290108694901 | Conical 2mm Straight Healing Cap |
| 07290108694895 | NP 5mm Straight Healing Cap |
| 07290108694888 | NP 3mm Straight Healing Cap |
| 07290108694871 | NP 2mm Straight Healing Cap |
| 07290108694864 | SP 5mm Straight Healing Cap |
| 07290108694857 | SP 3mm Straight Healing Cap |
| 07290108694840 | SP 2mm Straight Healing Cap |
| 07290108694833 | Final Depth Pin for 6.0 implant |
| 07290108694826 | Stepped Depth Pin 4.5/5.2 |
| 07290108694819 | Stepped Depth Pin 3.8/4.5 |
| 07290108694802 | Stepped Depth Pin 3.2/3.8 |
| 07290108694796 | Stepped Depth Pin 2.4/3.2 |
| 07290108694789 | Stepped Depth Pin 2.0/2.4 |
| 07290108694772 | Stepped Depth Pin 1.5/2.0 |
| 07290108694734 | 7mm Healing Cap Dia 4.5mm |
| 07290108694727 | 6mm Healing Cap Dia 4.5mm |
| 07290108694710 | NP 7mm Healing Cap |
| 07290108694703 | NP 6mm Healing Cap |
| 07290108694673 | NP Temporary Ti Abutment Non-Engage |
| 07290108694666 | NP Temporary Ti Abutment Engage |
| 07290108694659 | SP Temporary Ti Abutment Non-Engage |
| 07290108694642 | SP Temporary Ti Abutment Engage |
| 07290108694635 | 3mm Conical Non-Engage Ti Base Abutment |
| 07290108694628 | 3mm Conical Engage Ti Base Abutment |
| 07290108694529 | 3mm NP Non-Engage Ti Base Abutment |
| 07290108694512 | 3mm SP Non-Engage Ti Base Abutment |
| 07290108694505 | 3mm NP Engage Ti Base Abutment |
| 07290108694499 | 3mm SP Engage Ti Base Abutment |
| 07290108694352 | 1mm NP Non-Engage Ti Base Abutment |
| 07290108694345 | 1mm SP Non-Engage Ti Base Abutment |
| 07290108694130 | Pilot Drill 2mm dia 27mm length |
| 07290108694123 | Pilot Drill 2mm dia 23mm length |
| 07290108694116 | Pilot Drill 2mm dia 19mm length |
| 07290108694109 | Pilot Drill (Spade) For surgical guide |
| 07290108693317 | Premium Complete Surgical Kit |
| 07290108693300 | Compact Complete Surgical Kit |
| 07290108693287 | 1.25 Hex Short Manual Driver |
| 07290108693270 | Conical Close Tray Impression coping Dia 6mm |
| 07290108693263 | Conical Close Tray Impression coping Dia 4.5mm |
| 07290108693256 | Conical Open Tray Impression coping Dia 6mm |
| 07290108693249 | Conical Open Tray Impression coping Dia 4.5mm |
| 07290108693232 | Conical Standard Analog |
| 07290108693225 | Advanced Close Tray Multi Unit Impression coping |
| 07290108693218 | Advanced Open Tray Multi Unit Impression coping |
| 07290108693201 | Advanced Multi Unit Abutment Analog |
| 07290108693195 | Conical Platform Scan Abutment |
| 07290108693188 | Conical 7mm Healing Cap Dia 6mm |
| 07290108693171 | Conical 5mm Healing Cap Dia 6mm |
Trademark Results [Paltop]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PALTOP 87570958 5423163 Live/Registered |
Paltop Advanced Dental Solutions Ltd. 2017-08-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.