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FDA 510(k)

Infinity / Infinity Cross Flex Dental Systems

K-Number: K180935 · 2020-02-05

ApplicantOlsen Industria E Comercio S.A.
Decision Date2020-02-05
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Infinity / Infinity Cross Flex Dental Systems is a medical device manufactured by Olsen Industria E Comercio S.A.. It received FDA 510(k) clearance on 2020-02-05 under approval number K180935. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinity / Infinity Cross Flex Dental Systems?

Infinity / Infinity Cross Flex Dental Systems is a medical device that received FDA 510(k) clearance on 2020-02-05. It is manufactured by Olsen Industria E Comercio S.A.. The 510(k) number is K180935.

When was Infinity / Infinity Cross Flex Dental Systems approved by the FDA?

Infinity / Infinity Cross Flex Dental Systems received FDA 510(k) clearance on 2020-02-05, under approval number K180935.

What company makes Infinity / Infinity Cross Flex Dental Systems?

Infinity / Infinity Cross Flex Dental Systems is manufactured by Olsen Industria E Comercio S.A..

What is the FDA product code for Infinity / Infinity Cross Flex Dental Systems?

The FDA product code for Infinity / Infinity Cross Flex Dental Systems is EIA.

Related Clinical Trials

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING NCT05585905 Virtual Reality in Pediatric Dentistry COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07581938 Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

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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.

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