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FDA 510(k)

SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200

K-Number: K091533 · 2009-08-17

Decision Date2009-08-17
Product CodeJEP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 is the device name listed in this FDA 510(k) record. The listed applicant is Garrison Dental Solutions. It received FDA 510(k) clearance on 2009-08-17 under 510(k) number K091533. The device is classified under product code JEP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200?

SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 is a medical device that received FDA 510(k) clearance on 2009-08-17. The listed applicant is Garrison Dental Solutions. The 510(k) number is K091533.

When did SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 receive FDA 510(k) clearance?

SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 received FDA 510(k) clearance on 2009-08-17, under 510(k) number K091533.

Who is the listed applicant for SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200?

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

What is the FDA product code for SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200?

The FDA product code for SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 is JEP.

Related Clinical Trials

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.

Related Devices (Code: JEP)

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.

Official Source

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