GlassLok GLP15

GUDID D798GLP150

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. 15 gm Powder Component

RELIANCE ORTHODONTIC PRODUCTS INC

Glass ionomer dental cement

• Primary Device ID: D798GLP150
• NIH Device Record Key: 2b92c790-e2ee-40ba-a77f-52a972853a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlassLok
• Version Model Number: GLP15
• Catalog Number: GLP15
• 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: true
• 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

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)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798GLP150 [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