SIMPLANT®

GUDID 07392532185236

Other Custom Guide

DENTSPLY IH, INC.

Surgical drill guide, single-use, sterile

• Primary Device ID: 07392532185236
• NIH Device Record Key: e769281c-bc68-4683-ab2f-8132278365a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLANT®
• Version Model Number: 54500228
• Company DUNS: 847337201
• Company Name: DENTSPLY IH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	07392532185236 [Primary]

FDA Product Code

• NDP: Accessories, implant, dental, endosseous

Sterilization

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

[07392532185236]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-30

On-Brand Devices [SIMPLANT®]

• 07392532185236: Other Custom Guide
• 07392532185229: Extra Custom Guide
• 07392532177064: SIMPLANT Guide