Lime Lite Enhanced

GUDID D701LLE32

3 mL/ 5 gm syringe + 20 tips

PULPDENT CORPORATION

Dental composite resin

• Primary Device ID: D701LLE32
• NIH Device Record Key: 1bac67c8-51d5-481a-98eb-db412fe65525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lime Lite Enhanced
• Version Model Number: LLE3
• 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: 3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D701LLE32 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153249

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: 5
• Public Version Date: 2019-11-11
• Device Publish Date: 2018-08-10

Devices Manufactured by PULPDENT CORPORATION

• D701T20G191 - Applicator Tips: 2024-12-11 Automix Tips, clear, with bendable 19-gauge metal cannula - Pkg of 20
• D701SVBFUS2 - ACTIVA™ BioACTIVE Bulk Flow: 2024-12-10 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample
• D701SVKBFUS2 - ACTIVA™ Kids BioACTIVE Bulk Flow: 2024-12-10 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample
• D701VBF1US2 - ACTIVA™ BioACTIVE Bulk Flow: 2024-12-10 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion)
• D701VKBF1OW2 - ACTIVA™ Kids BioACTIVE Bulk Flow: 2024-12-10 1 x 3mL / 5gm syringe + 10 Automix tips, opaque white shade
• D710VKBF1US2 - ACTIVA™ Kids BioACTIVE Bulk Flow: 2024-12-10 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion)
• D701SUNO2 - DENTASTIC UNO SAMPLE: 2024-02-16 Adhesive, dentine, applicator brush
• D701SVPFA32 - Activa Presto: 2023-06-30 .6 mL sample A3 shade + 5 tips