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FDA 510(k)

PRECAPSULED DENTAL AMALGAM

K-Number: K822610 · 1982-09-14

ApplicantSyntex Dental Products, Inc.
Decision Date1982-09-14
Product CodeDZS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRECAPSULED DENTAL AMALGAM is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Dental Products, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822610. The device is classified under product code DZS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECAPSULED DENTAL AMALGAM?

PRECAPSULED DENTAL AMALGAM is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Syntex Dental Products, Inc.. The 510(k) number is K822610.

When did PRECAPSULED DENTAL AMALGAM receive FDA 510(k) clearance?

PRECAPSULED DENTAL AMALGAM received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822610.

Who is the listed applicant for PRECAPSULED DENTAL AMALGAM?

The FDA 510(k) record lists Syntex Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECAPSULED DENTAL AMALGAM?

The FDA product code for PRECAPSULED DENTAL AMALGAM is DZS.

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Other records listing Syntex Dental Products, Inc. as applicant

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Related Devices (Code: DZS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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