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)

NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM

K-Number: K895401 · 1989-12-04

ApplicantRocky Mountain Orthodontics, Inc.
Decision Date1989-12-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rocky Mountain Orthodontics, Inc.. It received FDA 510(k) clearance on 1989-12-04 under 510(k) number K895401. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM?

NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-04. The listed applicant is Rocky Mountain Orthodontics, Inc.. The 510(k) number is K895401.

When did NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM receive FDA 510(k) clearance?

NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM received FDA 510(k) clearance on 1989-12-04, under 510(k) number K895401.

Who is the listed applicant for NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM?

The FDA 510(k) record lists Rocky Mountain Orthodontics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM?

The FDA product code for NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM is EBF.

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 Rocky Mountain Orthodontics, Inc. 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.

K843527ORTHOMITE 111 ADHESIVEK780678IMPRESSION TRAYK780334ADHESIVE, BRACKET AND CONDITIONER RESINK780170ORTHODONTIC BRACKET PADSK780205ORTHODONTIC BUCCAL TUBE

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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.

↑