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FDA 510(k)

UNIVERSAL MAXILLARY MOLAR

K-Number: K110337 · 2012-03-16

ApplicantOco Biomedical
Decision Date2012-03-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL MAXILLARY MOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Oco Biomedical. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K110337. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL MAXILLARY MOLAR?

UNIVERSAL MAXILLARY MOLAR is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Oco Biomedical. The 510(k) number is K110337.

When did UNIVERSAL MAXILLARY MOLAR receive FDA 510(k) clearance?

UNIVERSAL MAXILLARY MOLAR received FDA 510(k) clearance on 2012-03-16, under 510(k) number K110337.

Who is the listed applicant for UNIVERSAL MAXILLARY MOLAR?

The FDA 510(k) record lists Oco Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL MAXILLARY MOLAR?

The FDA product code for UNIVERSAL MAXILLARY MOLAR is DZE.

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Other records listing Oco Biomedical 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.

K1221986.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEMK090174TSI; ERIK080115I-MINI DENTAL IMPLANT

Related Devices (Code: DZE)

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.

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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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