FDA.reportPublic FDA data

Neodent

Primary DI
07899878056348
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
110316
Catalog number
110316
Device description
Pre-Mounted Helix NGM Compact Surgical Kit Case
Published
2022-05-03
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
K214051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214051000Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.2022-04-13KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878056348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878056348078998780563487899878056348

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length195Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from Sunlight
Storage Environment Temperature040 Degrees Celsius

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
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
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
07899878066927Neodent191.109191.1092026-06-24
07899878066934Neodent191.110191.1102026-06-24
07899878066941Neodent191.111191.1112026-06-24
07899878066958Neodent191.112191.1122026-06-24
07899878066965Neodent191.113191.1132026-06-24
07899878066972Neodent191.114191.1142026-06-24
07899878064985Neodent103.697103.6972026-03-18
07899878064992Neodent103.698103.6982026-03-18
07899878065005Neodent103.699103.6992026-03-18
07899878065012Neodent103.700103.7002026-03-18
07899878065029Neodent103.701103.7012026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817766026355X-Series CaseTecometKCT2026-09-04
00817766026362X-Series CaseTecometKCT2026-09-04
00817766026379X-Series CaseTecometKCT2026-09-04
00817766026386X-Series CaseTecometKCT2026-09-04
00817766026393X-Series CaseTecometKCT2026-09-04
00817766026430X-Series CaseTecometKCT2026-09-04
00817766026447X-Series CaseTecometKCT2026-09-04
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26