Paltop

GUDID 07290114694551

Snap-On Abutment System (SAS) Internal Hex. NP Ø4.5mm L5.5mm H2mm

PALTOP ADVANCED DENTAL SOLUTIONS LTD

Dental implant suprastructure kit

• Primary Device ID: 07290114694551
• NIH Device Record Key: 224ab016-8dea-4abe-b64e-89a5cc82e4cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paltop
• Version Model Number: 44-70027
• Company DUNS: 533836024
• Company Name: PALTOP ADVANCED DENTAL SOLUTIONS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290114694551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130462

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

[07290114694551]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

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