American Dental Implant TH3503

GUDID D896TH35030

3.5mm Tissue Healing Abutment 3mm Neck

AMERICAN DENTAL IMPLANT CORPORATION

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D896TH35030
• NIH Device Record Key: fcbb22f4-e409-4ea5-b161-b29a67d26492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: American Dental Implant
• Version Model Number: TH3503
• Catalog Number: TH3503
• Company DUNS: 835556429
• Company Name: AMERICAN DENTAL IMPLANT 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

Customer Support Contacts

• Phone: 8005110661
• Email: info@americandentalimplant.com
• Phone: 8005110661
• Email: info@americandentalimplant.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D896TH35030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080397

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D896TH35030]

Moist Heat or Steam Sterilization

[D896TH35030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-07-31

On-Brand Devices [American Dental Implant]

• D896WDCS0: 4.5mm First Stage Surgical Cover Screw (.050 Hex Drive)
• D896TH5765050: 5.7/6.5mm Flared Emergence Profile Tissue Healing Abutment 5mm Neck
• D896TH5765030: 5.7/6.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck
• D896TH4555050: 4.5/5.5mm Flared Emergence Profile Tissue Healing Abutment 5mm Neck
• D896TH4555030: 4.5/5.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck
• D896TH45050: 4.5mm Tissue Healing Abutment 5mm Neck
• D896TH45030: 4.5mm Tissue Healing Abutment 3mm Neck
• D896TH3545050: 3.5/4.5mm Flared Emergence Profile Tissue Healing Abutment 5mm Neck
• D896TH3545030: 3.5/4.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck
• D896TH35050: 3.5mm Tissue Healing Abutment 5mm Neck
• D896TH35030: 3.5mm Tissue Healing Abutment 3mm Neck
• D896TH30050: 3.0mm Tissue Healing Abutment 5mm Neck
• D896TH30030: 3.0mm Tissue Healing Abutment 3mm Neck
• D896TH30020: 3.0mm Tissue Healing Abutment 2mm Neck
• D896TD600: 6mm Trephine Drill
• D896TD500: 5mm Trephine Drill
• D896TD400: 4mm Trephine Drill
• D896T6016RBM0: 6.0mm x 16mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T6016HA0: 6.0mm x 16mm XL Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T6013RBM0: 6.0mm x 13mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T6013HA0: 6.0mm x 13mm XL Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T60115RBM0: 6.0mm x 11.5mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T60115HA0: 6.0mm x 11.5mm XL Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T6010RBM0: 6.0mm x 10mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T6010HA0: 6.0mm x 10mm XL Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T6008RBM0: 6.0mm x 08mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T6008HA0: 6.0mm x 08mm XL Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T4716RBM0: 4.7mm x 16mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T4716HA0: 4.7mm x 16mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T4713RBM0: 4.7mm x 13mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T4713HA0: 4.7mm x 13mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T47115RBM0: 4.7mm x 11.5mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T47115HA0: 4.7mm x 11.5mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T4710RBM0: 4.7mm x 10mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T4710HA0: 4.7mm x 10mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T4708RBM0: 4.7mm x 08mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T4708HA0: 4.7mm x 08mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T3716RBM0: 3.7mm x 16mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T3716HA0: 3.7mm x 16mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T3713RBM0: 3.7mm x 13mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T3713HA0: 3.7mm x 13mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T37115RBM0: 3.7mm x 11.5mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T37115HA0: 3.7mm x 11.5mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T3710RBM0: 3.7mm x 10mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T3710HA0: 3.7mm x 10mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T3708RBM0: 3.7mm x 08mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface
• D896T3708HA0: 3.7mm x 08mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface
• D896T3216RBM0: 3.2mm x 16mm Tapered Internal Hex Dental Implant RBM Surface
• D896T3216HA0: 3.2mm x 16mm Tapered Internal Hex Dental Implant HA Surface
• D896T3213RBM0: 3.2mm x 13mm Tapered Internal Hex Dental Implant RBM Surface