RevoCone Cone 43061002

GUDID EBRE430610029

RevoCone Cone 2 pieces

bredent GmbH & Co. KG

Resilient dental precision attachment
Primary Device IDEBRE430610029
NIH Device Record Keyc143a214-61b4-41c6-990f-92bbd240d6fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevoCone Cone
Version Model Number43061002
Catalog Number43061002
Company DUNS341086190
Company Namebredent GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBRE430610020 [Primary]
HIBCCEBRE430610029 [Package]
Contains: EBRE430610020
Package: dummy [1 Units]
Discontinued: 2024-01-30
Not in Commercial Distribution

FDA Product Code

EGGATTACHMENT, PRECISION, ALL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-07
Device Publish Date2024-01-30

Devices Manufactured by bredent GmbH & Co. KG

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EBREVLCOLBODYA9 - visio.lign color Body A2025-03-18 visio.lign color Body A 2.6 ml
EBREVLCOLBODYB9 - visio.lign color Body B2025-03-18 visio.lign color Body B 2.6 ml
EBREVLCOLBODYC9 - visio.lign color Body C2025-03-18 visio.lign color Body C 2.6 ml
EBREVLCOLBODYD9 - visio.lign color Body D2025-03-18 visio.lign color Body D 2.6 ml
EBREVLCOLBROWN9 - visio.lign color Brown2025-03-18 visio.lign color Brown 2.6 ml
EBREVLCOLCREME9 - visio.lign color Creme2025-03-18 visio.lign color Creme 2.6 ml

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