FDA.reportPublic FDA data

Neodent

Primary DI
07899878061151
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
110.335
Catalog number
110.335
Device description
COMPLEMENT CASE (MODEL 2)
Published
2023-08-18
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
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230804000Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.2023-07-07KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878061151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878061151078998780611517899878061151

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags#

DUNS number
906713888
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899878068181Neodent118.413118.4132026-09-25
07899878068198Neodent118.414118.4142026-09-25
07899878068211Neodent138.196138.1962026-09-25
07899878068228Neodent138.197138.1972026-09-25
07899878068235Neodent116.309116.3092026-09-25
07899878068242Neodent116.308116.3082026-09-25
07899878068259Neodent118.415118.4152026-09-25
07899878068266Neodent104.075104.0752026-09-25
07899878068273Neodent104.078104.0782026-09-25
07899878068280Neodent104.076104.0762026-09-25
07899878068297Neodent104.077104.0772026-09-25
07899878066989Neodent106.281106.2812026-07-03
07899878066996Neodent106.282106.2822026-07-03
07899878067009Neodent106.283106.2832026-07-03
07899878067016Neodent106.284106.2842026-07-03
07899878067023Neodent106.285106.2852026-07-03
07899878067030Neodent106.286106.2862026-07-03
07899878067047Neodent106.287106.2872026-07-03
07899878067054Neodent106.288106.2882026-07-03
07899878067061Neodent106.289106.2892026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24
00724995237080V. MuellerSteris CorporationKCT2026-09-24
00724995237097V. MuellerSteris CorporationKCT2026-09-24
00724995237103V. MuellerSteris CorporationKCT2026-09-24
00724995237110V. MuellerSteris CorporationKCT2026-09-24
00724995237127V. MuellerSteris CorporationKCT2026-09-24
00724995237134V. MuellerSteris CorporationKCT2026-09-24
00724995237141V. MuellerSteris CorporationKCT2026-09-24
00724995237158V. MuellerSteris CorporationKCT2026-09-24
00724995237165V. MuellerSteris CorporationKCT2026-09-24
00724995237172V. MuellerSteris CorporationKCT2026-09-24
00724995237189V. MuellerSteris CorporationKCT2026-09-24
00724995237196V. MuellerSteris CorporationKCT2026-09-24
00724995237202V. MuellerSteris CorporationKCT2026-09-24
00724995237219V. MuellerSteris CorporationKCT2026-09-24
00724995237226V. MuellerSteris CorporationKCT2026-09-24
00724995237233V. MuellerSteris CorporationKCT2026-09-24
00724995237240V. MuellerSteris CorporationKCT2026-09-24
00724995237257V. MuellerSteris CorporationKCT2026-09-24
00724995237264V. MuellerSteris CorporationKCT2026-09-24
00724995237271V. MuellerSteris CorporationKCT2026-09-24
00724995237288V. MuellerSteris CorporationKCT2026-09-24
00724995237295V. MuellerSteris CorporationKCT2026-09-24
00724995237301V. MuellerSteris CorporationKCT2026-09-24