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FDA 510(k)

SMYLON (DENTAL STAIN ERASER)

K-Number: K891338 · 1989-11-14

ApplicantThe Smylon Co.
Decision Date1989-11-14
Product CodeMAU
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMYLON (DENTAL STAIN ERASER) is the device name listed in this FDA 510(k) record. The listed applicant is The Smylon Co.. It received FDA 510(k) clearance on 1989-11-14 under 510(k) number K891338. The device is classified under product code MAU. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMYLON (DENTAL STAIN ERASER)?

SMYLON (DENTAL STAIN ERASER) is a medical device that received FDA 510(k) clearance on 1989-11-14. The listed applicant is The Smylon Co.. The 510(k) number is K891338.

When did SMYLON (DENTAL STAIN ERASER) receive FDA 510(k) clearance?

SMYLON (DENTAL STAIN ERASER) received FDA 510(k) clearance on 1989-11-14, under 510(k) number K891338.

Who is the listed applicant for SMYLON (DENTAL STAIN ERASER)?

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

What is the FDA product code for SMYLON (DENTAL STAIN ERASER)?

The FDA product code for SMYLON (DENTAL STAIN ERASER) is MAU.

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Related Devices (Code: MAU)

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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