Predicta™ S631

GUDID 00810000525645

Predicta™ Cement Universal (Shade A2)

PARKELL, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 00810000525645
• NIH Device Record Key: 84c7b4d5-3772-4f3f-a129-2a092e406ec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Predicta™
• Version Model Number: S631
• Catalog Number: S631
• Company DUNS: 009900424
• Company Name: PARKELL, 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525645 [Primary]

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: 2022-05-09
• Device Publish Date: 2022-04-29

On-Brand Devices [Predicta™]

• 00810000525461: Predicta™ Bioactive Bulk Dual-Cure Restorative A2/B2 Bulk Fill
• 00810000525454: Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Bulk Fill
• 00810000525447: Predicta™ Bioactive Bulk Dual-Cure Restorative A2/B2 Bulk Fill (LV)
• 00810000525430: Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Bulk Fill (LV)
• 00810000525423: Predicta™ Bioactive Core Dual-Cure Core Build-up Material Tooth Stackable
• 00810000525416: Predicta™ Bioactive Core Dual-Cure Core Build-up Material White Stackable
• 00810000525409: Predicta™ Bioactive Core Dual-Cure Core Build-up Material Tooth Flowable
• 00810000525393: Predicta™ Bioactive Core Dual-Cure Core Build-up Material White Flowable
• 10810000527615: 19-Guage Dispensing Tips for Predicta™ Materials (30 pcs)
• 10810000527608: 17-Guage Dispensing Tips for Predicta™ Materials (30 pcs)
• 00810000527595: 5ml Dispensing Gun for Predicta™ Materials
• 10810000525529: Predicta™ Bioactive Desensitizer Gel
• 00810000525539: Predicta™ Bioactive Desensitizer Gel 1-Syringe
• 00810000525652: Predicta™ Cement (Opaque)
• 00810000525645: Predicta™ Cement Universal (Shade A2)
• 00810000525638: Predicta™ Cement (Tranlucent)