FDA.reportPublic FDA data

IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM

Primary DI
07899995273963
Brand
IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM
Company
Sin Sistema de Implante Nacional S/A
Model
ILM 5011N
Catalog number
ILM 5011N
Device description
IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222231000S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.2022-10-27DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995273963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995273963078999952739637899995273963

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
904569092
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BPFCM 01BPFCM 01B2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD APFCM 01APFCM 01A2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BPFMT 01BPFMT 01B2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD APFMT 01APFMT 01A2026-07-22
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGCTA 01ELCTA 01EL2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGCTA 01LCTA 01L2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMCTA 01MCTA 01M2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGCCA 01ELCCA 01EL2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGCCA 01LCCA 01L2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMCCA 01MCCA 01M2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTCCA 01CCCA 01C2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTCCA 01ECCCA 01EC2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGCCER 18LCCER 18L2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMCCER 18MCCER 18M2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTCCER 18CCCER 18C2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGCCER 16LCCER 16L2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTCCER 16CCCER 16C2026-07-14
07899995235541RATCHET RETRIEVER DRIVER M1.6 MEDIUMCCER 16MCCER 16M2026-06-23
07899995279668Abutment ScrewPRH 30 PACK4PRH 30 PACK42026-03-13
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114711548prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114711630prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114712491prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
08809984970420S-PlantIDIS CO.,LTDDZE2026-10-07
07290114712149prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712767prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712774prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712781prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712798prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712804prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712811prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712828prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712835prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712842prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06