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FDA 510(k)

PROSTYLE INTRA

K-Number: K970975 · 1997-04-01

ApplicantPlanmeca Oy
Decision Date1997-04-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROSTYLE INTRA is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 1997-04-01 under 510(k) number K970975. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTYLE INTRA?

PROSTYLE INTRA is a medical device that received FDA 510(k) clearance on 1997-04-01. The listed applicant is Planmeca Oy. The 510(k) number is K970975.

When did PROSTYLE INTRA receive FDA 510(k) clearance?

PROSTYLE INTRA received FDA 510(k) clearance on 1997-04-01, under 510(k) number K970975.

Who is the listed applicant for PROSTYLE INTRA?

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

What is the FDA product code for PROSTYLE INTRA?

The FDA product code for PROSTYLE INTRA is EHD.

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Other records listing Planmeca Oy 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.

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Related Devices (Code: EHD)

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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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