Crown Lok 1SMCLB

GUDID D7981SMCLB0

Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is the Self Mixing dispensing in Blue Shade.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental prosthesis veneer resin

• Primary Device ID: D7981SMCLB0
• NIH Device Record Key: 421e747d-37fb-4d5a-9168-997c53d3127b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crown Lok
• Version Model Number: 1SMCLB
• Catalog Number: 1SMCLB
• 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: false
• 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: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.com
• Phone: 630-773-4009
• Email: pgange@relianceorthodontics.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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7981SMCLB0 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2020-07-27
• Device Publish Date: 2020-07-19

On-Brand Devices [Crown Lok]

• D798SMCLBK0: Crown Lok is intended for use as a cement for metal crowns and orthodontic bands. This is the S
• D798SMCLB0: Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is th
• D7981SMCLB0: Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is th