LIME-LITE

GUDID D701LIME2

Kit: 4 x 1.2 mL syringes + 8 applicator tips Light curve cavity liner

PULPDENT CORPORATION

Calcium hydroxide dental cement

• Primary Device ID: D701LIME2
• NIH Device Record Key: 24187dd7-3dcc-4bb1-81b4-1e9e589345d0
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LIME-LITE
• Version Model Number: LIME
• Company DUNS: 001006089
• Company Name: PULPDENT CORPORATION
• 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: true
• 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 Dimensions

• Total Volume: 1.2 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D701LIME2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953079

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-26
• Device Publish Date: 2016-08-11

On-Brand Devices [LIME-LITE ]

• D701LIME32: 3 mL syringe Light cure cavity liner
• D701LIME2: Kit: 4 x 1.2 mL syringes + 8 applicator tips Light curve cavity liner