Universal Shapers

GUDID 00860014936623

A specialized dental instrument used for bone profiling, shaping, and sculpting in implant dentistry. These drills are designed to create a "scalloped" or contoured bone profile around the platform of dental implants to better match the natural, anatomical shape of the bone, particularly in the esthetic zone (anterior maxilla).

UNIVERSAL SHAPERS LLC

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 00860014936623
• NIH Device Record Key: a938571c-2a84-481e-a92d-d58f2e006275
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Shapers
• Version Model Number: Scalloping Drill SS5
• Company DUNS: 104090226
• Company Name: UNIVERSAL SHAPERS LLC
• 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: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014936623 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

[00860014936623]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-13
• Device Publish Date: 2026-03-05

On-Brand Devices [Universal Shapers]

• 00860014936647: A specialized dental instrument used for bone profiling, shaping, and sculpting in implant denti
• 00860014936630: A specialized dental instrument used for bone profiling, shaping, and sculpting in implant denti
• 00860014936616: A specialized surgical instrument used in dentistry, particularly during implant placement or gu
• 00860014936609: A specialized surgical instrument used in dentistry, particularly during implant placement or gu
• 00860014936623: A specialized dental instrument used for bone profiling, shaping, and sculpting in implant denti