Celtra

GUDID D0016012290

Celtra Duo Correction Porcelain

Dentsply International Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D0016012290
• NIH Device Record Key: 1ab723f1-d7b2-441f-8b14-136b34f46cc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celtra
• Version Model Number: 601229
• Company DUNS: 606173334
• Company Name: Dentsply International 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: true
• 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
HIBCC	D0016012290 [Primary]

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [Celtra]

• D0016012290: Celtra Duo Correction Porcelain
• D0016152060: Celtra Ceram Enamel - E6, Dark, 15G
• D0016152061: Celtra Ceram Enamel - E6, Dark, 15G