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

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• D745701071SRG03780 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Bone Profiler - Ø3.5
• D745701071SRG03790 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Bone Profiler - Ø4.3
• D745701071SRG03800 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Bone Profiler - Ø5.0
• D745701071SRG03870 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Guided Pilot Drill - Ø3.0 x 8 mm
• D745701071SRG03880 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Guided Pilot Drill - Ø3.5 x 8 mm
• D745701071SRG03890 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Guided Pilot Drill - Ø3.5 x 10 mm
• D745701071SRG03900 - Glidewell HT™: 2025-04-15 Glidewell HT™ Implant Guided Pilot Drill - Ø3.5 x 13 mm