Amerian Dental Implant 3713RBM

GUDID D8963713RBM0

3.7mm x 13mm Standard Diameter Internal Hex Dental Implant RBM Surface

AMERICAN DENTAL IMPLANT CORPORATION

Screw endosteal dental implant, two-piece

• Primary Device ID: D8963713RBM0
• NIH Device Record Key: 9948beeb-797a-409d-ab84-08f8ae66a7b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amerian Dental Implant
• Version Model Number: 3713RBM
• Catalog Number: 3713RBM
• 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: true
• 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: 800-511-0661
• Email: info@americandentalimplant.com
• Phone: 800-511-0661
• Email: info@americandentalimplant.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8963713RBM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042462

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: 2018-08-31
• Device Publish Date: 2018-07-31

Devices Manufactured by AMERICAN DENTAL IMPLANT CORPORATION

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• D896325013SD0 - American Dental Implant: 2024-04-12 3.25mm x 13mm Small Diameter External Hex Dental Implant
• D896325015SD0 - American Dental Implant: 2024-04-12 3.25mm x 15mm Small Diameter External Hex Dental Implant
• D896ADTD200 - American Dental Implant: 2020-01-09 2.0mm Diameter Externally Irrigated Twist Pilot Drill (38mm Length)
• D896ADTD20S0 - American Dental Implant: 2020-01-09 2.0mm Diameter Externally Irrigated Twist Pilot Drill Short (28mm Length)
• D896ADTD230 - American Dental Implant: 2020-01-09 2.3mm Diameter Externally Irrigated Twist Drill (38mm Length)
• D896ADTD23S0 - American Dental Implant: 2020-01-09 2.3mm Diameter Externally Irrigated Twist Pilot Drill Short (28mm Length)