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)

CERAM-PRIME

K-Number: K002502 · 2000-11-08

ApplicantS & C Polymer GmbH
Decision Date2000-11-08
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAM-PRIME is the device name listed in this FDA 510(k) record. The listed applicant is S & C Polymer GmbH. It received FDA 510(k) clearance on 2000-11-08 under 510(k) number K002502. 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 CERAM-PRIME?

CERAM-PRIME is a medical device that received FDA 510(k) clearance on 2000-11-08. The listed applicant is S & C Polymer GmbH. The 510(k) number is K002502.

When did CERAM-PRIME receive FDA 510(k) clearance?

CERAM-PRIME received FDA 510(k) clearance on 2000-11-08, under 510(k) number K002502.

Who is the listed applicant for CERAM-PRIME?

The FDA 510(k) record lists S & C Polymer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAM-PRIME?

The FDA product code for CERAM-PRIME 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 S & C Polymer GmbH 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.

K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTK083062ROOT CANAL XRK083766PHOGLASS CEMK082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTK081702CARBOXYLATE CEM, PHOSPHATE CEMK042614S&C-SELF ETCH PR-BOND

View all 20 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.

↑