AVALON BIOMED

GUDID 06975718050309

SHENZHEN DENCO MEDICAL CO., LTD

Manual endodontic file/rasp, single-use
Primary Device ID06975718050309
NIH Device Record Keyf9cc1847-51b6-4637-93f8-62ea4df78f47
Commercial Distribution Discontinuation2023-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAVALON BIOMED
Version Model NumberSlimShaper sterile 21mm ZS1
Company DUNS543035008
Company NameSHENZHEN DENCO MEDICAL CO., LTD
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975718050309 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


[06975718050309]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-16
Device Publish Date2023-08-08

On-Brand Devices [AVALON BIOMED]

06975718050620ApicalShaper sterile 25mm Z35/03
06975718050606ApicalShaper sterile 31mm Z30/03
06975718050590ApicalShaper sterile 25mm Z30/03
06975718050583ApicalShaper sterile 21mm Z30/03
06975718050521Excalibur sterile 25mm E45
06975718050514Excalibur sterile 21mm E45
06975718050491Excalibur sterile 25mm E35
06975718050484Excalibur sterile 21mm E35
06975718050453Excalibur sterile 21mm E25
06975718050361SlimShaper sterie 25mm ZS3
06975718050354SlimShaper sterie 25mm ZS2
06975718050347SlimShaper sterie 25mm ZS1
06975718050323SlimShaper sterile 21mm ZS3
06975718050316SlimShaper sterile 21mm ZS2
06975718050309SlimShaper sterile 21mm ZS1
06975718050293SlimShaper sterile 21mm ZS1-ZS3
06975718050149BlueShaper sterile 25mm Z1
06975718050057BlueShaper sterile 21mm ZX-Z5
06975718050040BlueShaper sterile 19mm ZX
06975718059821BlueShaper PRO sterile files 16mm ZXS (6 units)
06975718059814Z-Glider EVO sterile files 31mm
06975718059807Z-Glider EVO sterile files 25mm
06975718059791Z-Glider EVO sterile files 21mm
06975718059784SlimShaper PRO sterile files 31mm ZS1-ZS3 (6 units
06975718059777SlimShaper PRO sterile files 25mm ZS1-ZS3 (6 units
06975718059760SlimShaper PRO sterile files 21mm ZS1-ZS3 (6 units
06975718059739BlueShaper PRO sterile files 25mm ZX-Z5 (6 units)
06975718059722BlueShaper PRO sterile files 21mm ZX-Z5 (6 units)
06975718059708ApicalShaper sterile 25mm Z30-Z50 (4 units)
06975718059692ApicalShaper sterile 21mm Z30-Z50 (4 units)
06975718059678ApicalShaper sterile 25mm Z50/03 (6 units)
06975718059654ApicalShaper sterile 25mm Z40/03 (6 units)
06975718059647ApicalShaper sterile 25mm Z35/03 (6 units)
06975718059623ApicalShaper sterile 25mm Z30/03 (6 units)
06975718059616ApicalShaper sterile 21mm Z30/03 (6 units)
06975718059609Excalibur sterile 25mm E20-E45 (4 units)
06975718059593Excalibur sterile 21mm E20-E45 (4 units)
06975718059500SlimShaper sterile files 25mm ZS1-ZS3 (6 units)
06975718059494SlimShaper sterile files 21mm ZS1-ZS3 (6 units)
06975718059432Z-Gauge Ruler
06975718059425Endo-Block Ruler
06975718059418BlueShaper sterile files 31mm Z4 (6 units)
06975718059395BlueShaper sterile files 25mm Z6 (6 units)
06975718059340BlueShaper sterile files 25mm Z1 (6 units)
06975718059333BlueShaper sterile files 25mm ZX-Z5 (6 units)
06975718059296BlueShaper sterile files 21mm ZX-Z5 (6 units)
06975718056295Z-Glider EVO sterile files 25mm

Trademark Results [AVALON BIOMED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AVALON BIOMED
AVALON BIOMED
88253615 not registered Live/Pending
NuSmile, Ltd.
2019-01-08

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