Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM

K-Number: K072086 · 2007-10-26

ApplicantD B Orthodontics, Ltd.
Decision Date2007-10-26
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is D B Orthodontics, Ltd.. It received FDA 510(k) clearance on 2007-10-26 under 510(k) number K072086. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM?

INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-26. The listed applicant is D B Orthodontics, Ltd.. The 510(k) number is K072086.

When did INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM receive FDA 510(k) clearance?

INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM received FDA 510(k) clearance on 2007-10-26, under 510(k) number K072086.

Who is the listed applicant for INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM?

The FDA 510(k) record lists D B Orthodontics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM?

The FDA product code for INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM is OAT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing D B Orthodontics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100633INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

Related Devices (Code: OAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑