Renamel® Bulkfill 672235

GUDID EDEL6722350

Renamel® Bulkfill A3.5, 20 Compules

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL6722350
• NIH Device Record Key: 161ea7ef-52db-4c39-b564-db066f6fa559
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Bulkfill
• Version Model Number: 672235
• Catalog Number: 672235
• Company DUNS: 344805101
• Company Name: DeltaMed GmbH
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796722351 [Previous]
HIBCC	EDEL6722350 [Unit of Use]
HIBCC	EDEL6722351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211259

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Renamel® Bulkfill]

• EDEL6722D20: Renamel® Bulkfill D2, 20 Compules
• EDEL6722C30: Renamel® Bulkfill C3, 20 Compules
• EDEL6722B10: Renamel® Bulkfill B1, 20 Compules
• EDEL6722B00: Renamel® Bulkfill B-Zero, 20 Compules
• EDEL6722A30: Renamel® Bulkfill A3, 20 Compules
• EDEL6722A20: Renamel® Bulkfill A2, 20 Compules
• EDEL6722A10: Renamel® Bulkfill A1, 20 Compules
• EDEL6722350: Renamel® Bulkfill A3.5, 20 Compules