GlassLok GLEB

GUDID D798GLEB0

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. This is the Blue GlassLok Economy Kit Kit contains: 100g GlassLok Powder, 75g GlassLok Liquid, Spatula, Mixing Pad and Measuring Scoop

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798GLEB0
• NIH Device Record Key: 76d46942-8ff7-4a9b-a007-3cd5ec312a5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlassLok
• Version Model Number: GLEB
• Catalog Number: GLEB
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798GLEB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193388

FDA Product Code

• EMA: Cement, Dental

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: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [GlassLok]

• D798GLSB0: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLS0: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLP150: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLP1000: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLL25B0: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLL250: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLL15B0: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLL150: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLEB0: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
• D798GLE0: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic