RSVP Light Body 505LB0

GUDID D779505LB00

COSMEDENT, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D779505LB00
• NIH Device Record Key: e948fa08-b713-4a4d-85f0-57007c52dd3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RSVP Light Body
• Version Model Number: 505LB0
• Catalog Number: 505LB0
• Company DUNS: 113911689
• Company Name: COSMEDENT, 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: 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	D779505LB00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980800

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2016-09-22

On-Brand Devices [RSVP Light Body]

• D779505LS30: 505LS3
• D779505LD20: 505LD2
• D779505LB00: 505LB0
• D779505LA20: 505LA2
• D779505LA10: 505LA1