KISSES Plus Implant System AMS-35

GUDID 08800024952598

Multi Straight Abutment / M2.0 / Diameter: 4.8mm / Length: 11.5mm

Achimhai Medical Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800024952598
• NIH Device Record Key: 54968666-7a9a-4b40-81f1-50c346be4356
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KISSES Plus Implant System
• Version Model Number: AMS-35
• Catalog Number: AMS-35
• Company DUNS: 694197900
• Company Name: Achimhai Medical Corporation
• Device Count: 1
• DM Exempt: false
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800024952598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200193

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

[08800024952598]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-01
• Device Publish Date: 2021-08-24

On-Brand Devices [KISSES Plus Implant System]

• 08800024912479: Kisses Plus Implant System - Abutment Screw M2.0
• 08800024912462: Kisses Plus Implant System - Abutment Screw M1.6
• 08800024912455: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 25 degree
• 08800024912448: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 25 degree
• 08800024912431: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 25 degree
• 08800024912424: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 15 degree
• 08800024912417: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 15 degree
• 08800024912400: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 15 degree
• 08800024912394: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 25 degree
• 08800024912387: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 25 degree
• 08800024912370: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 25 degree
• 08800024912363: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 15 degree
• 08800024912356: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 15 degree
• 08800024912349: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 15 degree
• 08800024912332: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 25 degree
• 08800024912325: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 25 degree
• 08800024912318: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 25 degree
• 08800024912301: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 15 degree
• 08800024912295: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 15 degree
• 08800024912288: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 15 degree
• 08800024912271: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 25 degree
• 08800024912264: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 25 degree
• 08800024912257: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 25 degree
• 08800024912240: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 15 degree
• 08800024912233: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 15 degree
• 08800024912226: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 15 degree
• 08800024912219: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 25 degree
• 08800024912202: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 25 degree
• 08800024912196: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 25 degree
• 08800024912189: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 15 degree
• 08800024912172: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 15 degree
• 08800024912165: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 15 degree
• 08800024912158: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 25 degree
• 08800024912141: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 25 degree
• 08800024912134: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 25 degree
• 08800024912127: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 15 degree
• 08800024912110: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 15 degree
• 08800024912103: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 15 degree
• 08800024912097: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 25 degree
• 08800024912080: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 25 degree
• 08800024912073: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 25 degree
• 08800024912066: Kisses Plus Implant System Φ5.5, G/H 6.0, Angled 15 degree
• 08800024912059: Kisses Plus Implant System Φ5.5, G/H 4.0, Angled 15 degree
• 08800024912042: Kisses Plus Implant System Φ5.5, G/H 2.0, Angled 15 degree
• 08800024912035: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 25 degree
• 08800024912028: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 25 degree
• 08800024912011: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 25 degree
• 08800024912004: Kisses Plus Implant System Φ4.5, G/H 6.0, Angled 15 degree
• 08800024911991: Kisses Plus Implant System Φ4.5, G/H 4.0, Angled 15 degree
• 08800024911984: Kisses Plus Implant System Φ4.5, G/H 2.0, Angled 15 degree