RevoCone Cap yellow, 43061008

GUDID EBRE430610089

RevoCone Cap yellow, 8 N 4 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 IDEBRE430610089
NIH Device Record Keyca2f399d-c13c-4702-ac6e-8cccc1fc3cbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevoCone Cap yellow,
Version Model Number43061008
Catalog Number43061008
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 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
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBRE430610080 [Primary]
HIBCCEBRE430610089 [Package]
Contains: EBRE430610080
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

EBRE430610009 - RevoCone Cap white,2024-02-07 RevoCone Cap white, 0 N 4 pieces
EBRE430610019 - RevoCone Housing2024-02-07 RevoCone Housing 2 pieces
EBRE430610029 - RevoCone Cone2024-02-07 RevoCone Cone 2 pieces
EBRE430610049 - RevoCone Cap green,2024-02-07 RevoCone Cap green, 4 N 4 pieces
EBRE430610059 - RevoCone Starter Set2024-02-07 RevoCone Starter Set 1 matrix each 0 N, 8 N, 12 N 1 RevoCone Housing 4 parts
EBRE430610089 - RevoCone Cap yellow,2024-02-07RevoCone Cap yellow, 8 N 4 pieces
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.