3D Dental - Joy

GUDID 00817169020394

JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK C3

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental composite resin

• Primary Device ID: 00817169020394
• NIH Device Record Key: 30dbac45-b225-48ca-8089-0ff27f04857b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Dental - Joy
• Version Model Number: JF-C3
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169020394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994224

FDA Product Code

• EBF: Material, Tooth Shade, 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: 4
• Public Version Date: 2019-10-04
• Device Publish Date: 2016-12-14

On-Brand Devices [3D Dental - Joy]

• 00817169021698: Joy Bulk Fill Flow 2 x 2g Syringe
• 00817169020882: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe Opaque
• 00817169020875: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe OA3.5 (DENTIN)
• 00817169020868: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe OA3 (DENTIN)
• 00817169020851: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe OA2 (DENTIN)
• 00817169020844: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe OA1 (DENTIN)
• 00817169020837: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe Incisal
• 00817169020820: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe D4
• 00817169020813: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe D3
• 00817169020806: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe D2
• 00817169020790: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe C4
• 00817169020783: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe C3
• 00817169020776: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe C2
• 00817169020769: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe C1
• 00817169020752: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe B4
• 00817169020745: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe B3
• 00817169020738: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe B2
• 00817169020714: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe A4
• 00817169020707: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe A3.5
• 00817169020691: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe A3
• 00817169020684: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe A2
• 00817169020677: JOYFIL Nano-Hybrid Composite 4.5gm Refill Syringe A1
• 00817169020660: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm Opaque
• 00817169020653: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm OA3.5 (DENTIN)
• 00817169020646: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm OA3 (DENTIN)
• 00817169020639: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm OA2 (DENTIN)
• 00817169020622: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm OA1 (DENTIN)
• 00817169020615: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm Incisal
• 00817169020608: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm D4
• 00817169020592: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm D3
• 00817169020585: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm D2
• 00817169020578: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm C4
• 00817169020561: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm C3
• 00817169020554: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm C2
• 00817169020547: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm C1
• 00817169020530: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm B4
• 00817169020523: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm B3
• 00817169020516: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm B2
• 00817169020509: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm B1
• 00817169020493: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A4
• 00817169020486: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A3.5
• 00817169020479: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A3
• 00817169020462: JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A2
• 00817169020448: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK OPAQUER
• 00817169020431: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK INCISAL
• 00817169020424: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK D4
• 00817169020418: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK OPAQUER
• 00817169020417: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK D3
• 00817169020400: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK D2
• 00817169020394: JOYFIL FLOWABLE COMPOSITE REFILL 2GM 4/PK C3