RevoCone Cone 43061002

GUDID EBRE430610029

RevoCone Cone 2 pieces

bredent GmbH & Co. KG

Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment

• Primary Device ID: EBRE430610029
• NIH Device Record Key: c143a214-61b4-41c6-990f-92bbd240d6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoCone Cone
• Version Model Number: 43061002
• Catalog Number: 43061002
• Company DUNS: 341086190
• Company Name: bredent GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBRE430610020 [Primary]
HIBCC	EBRE430610029 [Package]; Contains: EBRE430610020; Package: dummy [1 Units]; Discontinued: 2024-01-30; Not in Commercial Distribution

FDA Product Code

• EGG: ATTACHMENT, PRECISION, ALL

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: 2024-02-07
• Device Publish Date: 2024-01-30

Devices Manufactured by bredent GmbH & Co. KG

• EBRE430610009 - RevoCone Cap white,: 2024-02-07 RevoCone Cap white, 0 N 4 pieces
• EBRE430610019 - RevoCone Housing: 2024-02-07 RevoCone Housing 2 pieces
• EBRE430610029 - RevoCone Cone: 2024-02-07RevoCone Cone 2 pieces
• EBRE430610029 - RevoCone Cone: 2024-02-07 RevoCone Cone 2 pieces
• EBRE430610049 - RevoCone Cap green,: 2024-02-07 RevoCone Cap green, 4 N 4 pieces
• EBRE430610059 - RevoCone Starter Set: 2024-02-07 RevoCone Starter Set 1 matrix each 0 N, 8 N, 12 N 1 RevoCone Housing 4 parts
• EBRE430610089 - RevoCone Cap yellow,: 2024-02-07 RevoCone Cap yellow, 8 N 4 pieces
• EBRE430610109 - RevoCone Cap white, green,: 2024-02-07 RevoCone Cap white, green, yellow, red, blue 2 matrices each 1 set
• EBRE430610129 - RevoCone Cap red,: 2024-02-07 RevoCone Cap red, 12 N 4 pieces