FDA.reportPublic FDA data

Ritter Implants Dental System

Primary DI
ERITNLCOD1811
Brand
Ritter Implants Dental System
Company
Ritter Implants GmbH & Co. KG
Model
NL-COD-18-1
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
ERITNLCOD1811PrimaryHIBCC0

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
ERITCODIT1Ritter Implants Dental SystemCOD-IT2023-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
00842092187661PreatPreat CorporationNHA2026-04-30
00842092187685PreatPreat CorporationNHA2026-04-30
00842092187708PreatPreat CorporationNHA2026-04-30
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2025-10-31
00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
00842092125656PreatPreat CorporationNHA2022-10-24
00842092126257PreatPreat CorporationNHA2022-10-24
00842092127001AstraPreat CorporationNHA2022-10-24
00842092127049AstraPreat CorporationNHA2022-10-24
00842092127087AstraPreat CorporationNHA2022-10-24
00842092127094AstraPreat CorporationNHA2022-10-24
00842092129210PreatPreat CorporationNHA2022-10-24
07630031717757Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic CopingInstitut Straumann AGNHA2022-04-14
07630031701565Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701572Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701602Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701619Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701626Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701633Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701640Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11