FDA.reportPublic FDA data

Ritter Implants Dental System

Primary DI
ERITCOD304P1
Brand
Ritter Implants Dental System
Company
Ritter Implants GmbH & Co. KG
Model
COD-30-4P
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
K180183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180183000Ritter Dental Implant SystemRitter Implants GmbH & Co. KG2019-01-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERITCOD304P1PrimaryHIBCC0

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
Contains natural rubber latex
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
ERITCOD3P1Ritter Implants Dental SystemCOD-3P2023-10-11
ERITCOD4P1Ritter Implants Dental SystemCOD-4P2023-10-11
ERITCODIT1Ritter Implants Dental SystemCOD-IT2023-10-11
ERITNLCOD1811Ritter Implants Dental SystemNL-COD-18-12023-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06