FDA.reportPublic FDA data

Ritter Dental Implant System

Primary DI
ERITTFI51152
Brand
Ritter Dental Implant System
Company
Ritter Implants GmbH & Co. KG
Model
TFI-5-11.5
Published
2016-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K131557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131557000RITTER IMPLANT SYSTEMRitter Implants GmbH CO KG2014-05-09DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERITTFI51152PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342602800
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ERITNLTTANEP1Ritter Dental Implant SystemNL-TTA-NEP2025-02-14
ERITNLTTANEPR1Ritter Dental Implant SystemNL-TTA-NEPR2025-02-14
ERITTTANEP1Ritter Dental Implant SystemTTA-NEP2025-02-14
ERITTTANEPR1Ritter Dental Implant SystemTTA-NEPR2025-02-14
ERITCOD1811Ritter Implants Dental SystemCOD-18-12023-10-11
ERITCOD181P1Ritter Implants Dental SystemCOD-18-1P2023-10-11
ERITCOD1821Ritter Implants Dental SystemCOD-18-22023-10-11
ERITCOD1831Ritter Implants Dental SystemCOD-18-32023-10-11
ERITCOD1841Ritter Implants Dental SystemCOD-18-42023-10-11
ERITCOD184P1Ritter Implants Dental SystemCOD-18-4P2023-10-11
ERITCOD2P1Ritter Implants Dental SystemCOD-2P2023-10-11
ERITCOD3011Ritter Implants Dental SystemCOD-30-12023-10-11
ERITCOD301P1Ritter Implants Dental SystemCOD-30-1P2023-10-11
ERITCOD3021Ritter Implants Dental SystemCOD-30-22023-10-11
ERITCOD302P1Ritter Implants Dental SystemCOD-30-2P2023-10-11
ERITCOD303P1Ritter Implants Dental SystemCOD-30-3P2023-10-11
ERITCOD304P1Ritter Implants Dental SystemCOD-30-4P2023-10-11
ERITCOD3P1Ritter Implants Dental SystemCOD-3P2023-10-11
ERITCOD4P1Ritter Implants Dental SystemCOD-4P2023-10-11
ERITCODIT1Ritter Implants Dental SystemCOD-IT2023-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970178S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970253S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970260S-PlantIDIS CO.,LTDDZE2026-10-20
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14