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)

PEAK BOND, MODEL 5133

K-Number: K063557 · 2006-12-12

ApplicantUltradent Products, Inc.
Decision Date2006-12-12
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEAK BOND, MODEL 5133 is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K063557. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEAK BOND, MODEL 5133?

PEAK BOND, MODEL 5133 is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K063557.

When did PEAK BOND, MODEL 5133 receive FDA 510(k) clearance?

PEAK BOND, MODEL 5133 received FDA 510(k) clearance on 2006-12-12, under 510(k) number K063557.

Who is the listed applicant for PEAK BOND, MODEL 5133?

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

What is the FDA product code for PEAK BOND, MODEL 5133?

The FDA product code for PEAK BOND, MODEL 5133 is KLE.

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 Ultradent Products, 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.

K262228Transcend Bulk Fill Flowable CompositeK261404UltraEZK240743Peak Universal BondK240694FORMA Composite (Shade A3D)K221909J-TempK220471VALO X, VALO X Accessory Lenses

View all 102 devices →

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.

↑