Renamel® Bulkfill 6722A3

GUDID EDEL6722A30

Renamel® Bulkfill A3, 20 Compules

DeltaMed GmbH

Dental composite resin
Primary Device IDEDEL6722A30
NIH Device Record Key72eacb33-46ff-4a21-8447-929d37848b32
Commercial Distribution StatusIn Commercial Distribution
Brand NameRenamel® Bulkfill
Version Model Number6722A3
Catalog Number6722A3
Company DUNS344805101
Company NameDeltaMed GmbH
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7796722A31 [Previous]
HIBCCEDEL6722A30 [Unit of Use]
HIBCCEDEL6722A31 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-08
Device Publish Date2023-05-31

On-Brand Devices [Renamel® Bulkfill]

EDEL6722D20Renamel® Bulkfill D2, 20 Compules
EDEL6722C30Renamel® Bulkfill C3, 20 Compules
EDEL6722B10Renamel® Bulkfill B1, 20 Compules
EDEL6722B00Renamel® Bulkfill B-Zero, 20 Compules
EDEL6722A30Renamel® Bulkfill A3, 20 Compules
EDEL6722A20Renamel® Bulkfill A2, 20 Compules
EDEL6722A10Renamel® Bulkfill A1, 20 Compules
EDEL6722350Renamel® Bulkfill A3.5, 20 Compules

Trademark Results [Renamel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RENAMEL
RENAMEL
79088119 not registered Dead/Abandoned
Sangi Co., Ltd.
2010-08-25
RENAMEL
RENAMEL
76580246 not registered Dead/Abandoned
Sangi Co., Ltd.
2004-03-10
RENAMEL
RENAMEL
74364089 not registered Dead/Abandoned
KABUSHIKI KAISHA SANGI
1993-03-01
RENAMEL
RENAMEL
73354552 1280429 Live/Registered
Cosmedent, Inc.
1982-03-15

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