FDA.report

Ritter Implants Dental System

Primary DI
ERITDI521
Brand
Ritter Implants Dental System
Company
Ritter Implants GmbH & Co. KG
Model
DI-5.2
Published
2023-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ERITDI521PrimaryHIBCC0

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
342602800
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ERITCTCFNC1Ritter Dental Implants SystemCT-CF-NC2025-11-18
ERITPAASVRP15101Ritter Dental Implants SystemPAA-SV-RP15102025-11-18
ERITPASVRP101Ritter Dental Implants SystemPA-SV-RP102025-11-18
ERITTAPARRPPK1Ritter Dental Implants SystemTAP-AR-RPPK2025-11-18
ERITTAPARRPSK1Ritter Dental Implants SystemTAP-AR-RPSK2025-11-18
ERITTTATSRPR1Ritter Dental Implants SystemTTA-TS-RPR2025-11-18
ERITACCTSVRP1500Ritter Implants Dental SystemACTT-SV-RP1500 2025-04-04
GMTSRP3508Ritter Dental Implant SystemGM-TS-RP35082025-04-02
GMTSRP3510Ritter Dental Implant SystemGM-TS-RP35102025-04-02
GMTSRP3511Ritter Dental Implant SystemGM-TS-RP35112025-04-02
GMTSRP3513Ritter Dental Implant SystemGM-TS-RP35132025-04-02
GMTSRP3515Ritter Dental Implant SystemGM-TS-RP35152025-04-02
GMTSRP4208Ritter Dental Implant SystemGM-TS-RP42082025-04-02
GMTSRP4210Ritter Dental Implant SystemGM-TS-RP42102025-04-02
GMTSRP4211Ritter Dental Implant SystemGM-TS-RP42112025-04-02
GMTSRP4213Ritter Dental Implant SystemGM-TS-RP42132025-04-02
GMTSRP4215Ritter Dental Implant SystemGM-TS-RP42152025-04-02
GMTSRP5006Ritter Dental Implant SystemGM-TS-RP50062025-04-02
GMTSRP5008Ritter Dental Implant SystemGM-TS-RP50082025-04-02
GMTSRP5010Ritter Dental Implant SystemGM-TS-RP50102025-04-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
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08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
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