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FDA 510(k)

POLYDIMETHYLSILOXANE IMPRESSION MATERIAL

K-Number: K131510 · 2013-12-20

ApplicantBlackwell Device Consulting
Decision Date2013-12-20
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYDIMETHYLSILOXANE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Blackwell Device Consulting. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K131510. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYDIMETHYLSILOXANE IMPRESSION MATERIAL?

POLYDIMETHYLSILOXANE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Blackwell Device Consulting. The 510(k) number is K131510.

When did POLYDIMETHYLSILOXANE IMPRESSION MATERIAL receive FDA 510(k) clearance?

POLYDIMETHYLSILOXANE IMPRESSION MATERIAL received FDA 510(k) clearance on 2013-12-20, under 510(k) number K131510.

Who is the listed applicant for POLYDIMETHYLSILOXANE IMPRESSION MATERIAL?

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

What is the FDA product code for POLYDIMETHYLSILOXANE IMPRESSION MATERIAL?

The FDA product code for POLYDIMETHYLSILOXANE IMPRESSION MATERIAL is ELW.

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Related Devices (Code: ELW)

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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