FDA.report

IMPLANT EPIKUT CM Ø4,5 X 24,0MM

Primary DI
07899995278142
Brand
IMPLANT EPIKUT CM Ø4,5 X 24,0MM
Company
Sin Sistema de Implante Nacional S/A
Model
ILCM 4524
Catalog number
ILCM 4524
Device description
IMPLANT EPIKUT CM Ø4,5 X 24,0MM
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K221453000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221453000S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.2022-12-15DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899995278142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899995278142078999952781427899995278142

GMDN Terms

TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods

Method

Regulatory Flags

DUNS number
904569092
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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