SCALEX

GUDID 00858466005127

Ultrasonic Scaler

DENTAMERICA, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00858466005127
• NIH Device Record Key: 78096467-2a19-4558-b39d-669f1967b686
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCALEX
• Version Model Number: 880P
• Company DUNS: 174436360
• Company Name: DENTAMERICA, INC.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858466005127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954820

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-05

On-Brand Devices [SCALEX]

• 00858466005165: Ultrasonic Scaler
• 00858466005158: Ultrasonic Scaler
• 00858466005141: Ultrasonic Scaler
• 00858466005134: Ultrasonic Scaler
• 00858466005127: Ultrasonic Scaler
• 00858466005110: Ultrasonic Scaler
• 00858466005103: Ultrasonic Scaler