Glidewell™ 70-1204-WPS0001

GUDID D745701204WPS00011

Glidewell™ Curing Light Kit

Prismatik Dentalcraft, Inc

Dental/surgical polymerization lamp

• Primary Device ID: D745701204WPS00011
• NIH Device Record Key: a03fd8e5-73e9-43a2-900b-c007435a1c25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glidewell™
• Version Model Number: 70-1204-WPS0001
• Catalog Number: 70-1204-WPS0001
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	D745701204WPS00011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080025

FDA Product Code

• EBZ: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

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: 2025-03-24
• Device Publish Date: 2025-03-14

Devices Manufactured by Prismatik Dentalcraft, Inc

• D745701204WPS00011 - Glidewell™: 2025-03-24Glidewell™ Curing Light Kit
• D745701204WPS00011 - Glidewell™: 2025-03-24 Glidewell™ Curing Light Kit
• D745701071SRG04040 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Shaping Drill – Ø6.0 x 8 mm
• D745701071SRG04050 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Shaping Drill – Ø6.0 x 10 mm
• D745701071SRG04060 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Shaping Drill – Ø6.0 x 11.5 mm
• D745701071SRG04070 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Screw Tap - Ø6.0 mm
• D745701071SRG04080 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Tissue Punch - Ø6.0 mm
• D745701071SRG04090 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Alignment Drill - Ø6.0 mm
• D745701071SRG04100 - Glidewell HT™: 2025-03-18 Glidewell HT™ Implant Guided Pilot Drill - Ø6.0 x 8 mm