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)

PROTEGE ULTRASONIC INSERT

K-Number: K051776 · 2005-07-13

ApplicantDiscus Dental, Inc.
Decision Date2005-07-13
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTEGE ULTRASONIC INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Discus Dental, Inc.. It received FDA 510(k) clearance on 2005-07-13 under 510(k) number K051776. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEGE ULTRASONIC INSERT?

PROTEGE ULTRASONIC INSERT is a medical device that received FDA 510(k) clearance on 2005-07-13. The listed applicant is Discus Dental, Inc.. The 510(k) number is K051776.

When did PROTEGE ULTRASONIC INSERT receive FDA 510(k) clearance?

PROTEGE ULTRASONIC INSERT received FDA 510(k) clearance on 2005-07-13, under 510(k) number K051776.

Who is the listed applicant for PROTEGE ULTRASONIC INSERT?

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

What is the FDA product code for PROTEGE ULTRASONIC INSERT?

The FDA product code for PROTEGE ULTRASONIC INSERT is ELC.

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 Discus Dental, 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.

K073518FLASHLITE REBEL*K062176RELIEF ACP ORAL CARE GELK052090SPLASH! IMPRESSION MATERIAL DEVICEK033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDEK040053PRECISION VPS IMPRESSION MATERIALK033381DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL

View all 10 devices →

Related Devices (Code: ELC)

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.

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence 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.

↑