OpaFit OPAFIT3HC

GUDID D815OPAFIT3HC1

VPS Heavy Body 50g Cartridge x 2 Dental impression material

OPA DENTAL LLC

Silicone dental impression material

• Primary Device ID: D815OPAFIT3HC1
• NIH Device Record Key: 4c4955b0-2efe-4f8f-b07e-c2c8c6be1fdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OpaFit
• Version Model Number: OPAFIT3HC
• Catalog Number: OPAFIT3HC
• Company DUNS: 053308044
• Company Name: OPA DENTAL LLC
• Device Count: 2
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D815OPAFIT3HC01 [Unit of Use]
HIBCC	D815OPAFIT3HC1 [Primary]

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: 2019-11-04
• Device Publish Date: 2018-09-20

On-Brand Devices [OpaFit]

• D815OPAFIT3HC1: VPS Heavy Body 50g Cartridge x 2 Dental impression material
• D815OPAFIT2LC1: VPS Light Body 50g x 2 Cartridge Dental impression material
• D815OPAFIT1P1: VPS putty 400g x 2 Dental impression material
• D815OPAFIT3HCLG0: VPS Heavy Body impression material 380ml Cartridge