FDA.reportPublic FDA data

Ritter Implants Dental System

Primary DI
ERITCODIT1
Brand
Ritter Implants Dental System
Company
Ritter Implants GmbH & Co. KG
Model
COD-IT
Published
2023-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160475000Ritter Dental Implant SystemRitter Implants GmbH & Co. KG2016-12-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERITCODIT1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342602800
Device count
1
Lot or batch
true
Sterilization required before use
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
ERITNLCOD1811Ritter Implants Dental SystemNL-COD-18-12023-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112922530(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922547(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922554(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922561(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922578(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922585(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922592(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922608(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922615(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922622(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922639(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922646(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922653(INOSS System) Abutment ScrewInosys, Inc.NHA2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217963OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217970OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217987OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217994OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218021OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218045OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218052OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218069OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218076OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218083OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218090OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218106OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218113OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218120OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27