FDA.reportPublic FDA data

Neodent

Primary DI
07899878058281
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
110.318
Catalog number
110.318
Device description
HELIX SHORT PRE-MOUNTED SURGICAL KIT CASE
Published
2023-06-15
Public version status
New
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
K223662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223662000Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.2023-04-20KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878058281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878058281078998780582817899878058281

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

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
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
07899878065036Neodent103.702103.7022026-03-18
07899878065043Neodent103.703103.7032026-03-18
07899878065050Neodent103.704103.7042026-03-18
07899878065067Neodent103.705103.7052026-03-18
07899878065074Neodent103.706103.7062026-03-18
07899878065081Neodent103.707103.7072026-03-18
07899878065098Neodent103.708103.7082026-03-18
07899878065104Neodent103.709103.7092026-03-18
07899878065111Neodent103.710103.7102026-03-18
07899878061151Neodent110.335110.3352023-08-18
07899878060062Neodent115.302115.3022023-11-18
07899878060079Neodent115.303115.3032023-11-18
07899878065128Neodent116.303116.3032024-12-19
07899878024521Neodent109.981109.9812017-08-18
07899878024583Neodent109.987109.9872017-08-18

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Primary DI, Brand, Company table
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07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178698MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177967MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15