DuraFinish™ S295

GUDID 00810000525188

DuraFinish™ Composite Glaze

PARKELL, INC.

Dental unfilled resin sealant/coating

• Primary Device ID: 00810000525188
• NIH Device Record Key: f00152ae-9c3c-4f89-a5ae-51127c11371c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraFinish™
• Version Model Number: S295
• Catalog Number: S295
• 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
• 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
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525188 [Primary]

FDA Product Code

• EBD: Coating, Filling Material, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-20
• Device Publish Date: 2018-10-26

On-Brand Devices [DuraFinish™]

• 00810000525195: All-Cure DuraFinish™ Composite Glaze
• 00810000525188: DuraFinish™ Composite Glaze
• M595S2960: All-Cure DuraFinish™ Composite Glaze
• M595S2950: DuraFinish™ Composite Glaze