LYGIN

GUDID 00858466005301

Alginate Impression Material

DENTAMERICA, INC.

Alginate dental impression material

• Primary Device ID: 00858466005301
• NIH Device Record Key: 6bf9c77b-3678-4aa3-8df8-d406cb7b2205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LYGIN
• Version Model Number: 230F
• 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: true
• 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	00858466005301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974704

FDA Product Code

• ELW: Material, Impression

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

Devices Manufactured by DENTAMERICA, INC.

• 00858466005103 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005110 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005127 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005134 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005141 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005158 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005165 - SCALEX: 2018-07-06 Ultrasonic Scaler
• 00858466005172 - LITEX: 2018-07-06 Curing Light