File-Eze

Primary DI
00883205105875
Brand
File-Eze
Company
ULTRADENT PRODUCTS, INC.
Model
682
Catalog number
682
Device description
File-Eze IndiSpense Refill
Published
2017-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJIRADIOIMMUNOASSAY, KANAMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJIRadioimmunoassay, KanamycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060335000FILE-EZEUltradent Products, Inc.2006-02-24KJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205105875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205105875008832051058758832051058750883205105875

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic reaming aid materialA liquid or gel substance typically used during root canal procedures as a chelating agent for chemical reaming to aid mechanical reaming, or as a lubricant to facilitate endodontic instrument penetration. It will typically have bactericidal properties. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius29 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00883205029119OpalDam1825-U1825-U2026-08-22
00883205029126OpalDam1826-U1826-U2026-08-22
00883205029133OpalDam324-U324-U2026-08-22
00883205029140OpalDam325-U325-U2026-08-22
00883205029157OpalDam326-U326-U2026-08-22
00883205041005Thermo Clone606560652026-08-22
00883205041883UltraCem205620562026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
00883205043344Valo X5973-DU5973-DU2026-08-22
00883205031976STARbrush109310932024-12-07
00883205040398Halo Sectional Matrix System588358832026-06-26
00883205040978Halo Sectional Matrix System588258822026-06-26
00883205044617Halo Sectional Matrix System993199312026-06-26
00883205044624Halo Sectional Matrix System993299322026-06-26
00883205044631Halo Sectional Matrix System993399332026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883205103468File-EzeULTRADENT PRODUCTS, INC.KJI2017-08-10
00883205105523Citric AcidULTRADENT PRODUCTS, INC.KJI2017-08-10