TYTIN R— 510(k) K951663

Substantially Equivalent

Kerr Corporation (Danbury)

FDA 510(k) clearance K951663 for TYTIN R, Substantially Equivalent on 1995-06-06. Applicant: Kerr Corporation (Danbury). Device class: 2.

Clearance details

Applicant: Kerr Corporation (Danbury)
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1995-04-10
Decision date: 1995-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJJ

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K033434 — BESTALOY2003-11-12
K032152 — BENCO ADMIX2003-08-06
K031658 — BENCO SPHERICAL2003-07-29

More clearances from Kerr Corporation (Danbury)

K051545 — L.E. DEMETRON II2005-07-18
K020091 — OPTILUX 5012002-03-21
K951511 — TYTIN ADMIX1995-05-02
K942480 — M4 CONTRA-ANGLE HANDPIECE1995-01-27
K940513 — OPTIBOND1994-04-15

Recalls naming K951663

K-number listed on FDA's recall record

Z-1788-2014 — Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.Class II·Terminated·Kerr Corporation·20140529

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951663.

Data sourced from openFDA. This site is unofficial and independent of the FDA.