Predicta™ S615

GUDID 00810000525454

Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Bulk Fill

PARKELL, INC.

Dental composite resin

• Primary Device ID: 00810000525454
• NIH Device Record Key: f2f25a88-ec23-4364-8386-ec2449bb9cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Predicta™
• Version Model Number: S615
• Catalog Number: S615
• 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: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store product tightly sealed and away from direct sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place, tightly sealed, away from direct sunlight. Do not freeze; use at room temperature. Do not store near eugenol containing materials.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525454 [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: 2019-04-08
• Device Publish Date: 2019-03-29

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)