Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth

Inclusion Criteria: * Male or female subjects who are 18 years of age or older; * requiring an operative restorative procedure on a single maxillary tooth with no evidence of pulpal pathology requiring local anesthesia; * having normal lip, nose, eyelid, and cheek sensations; * able to understand and sign the informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol; * having patency of naris on same side of head as tooth requiring the dental procedure. Exclusion Criteria: * Inadequately controlled hypertension (blood pressures greater than 150/90) or untreated coronary heart disease; * inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial thyroidectomy; * having frequent nose bleeds (10 per month); * having received dental care requiring a local anesthetic within the last 24 hours; * history of allergy to or intolerance of tetracaine, benzyl alcohol, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens); * history of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives; history of taking a monoamine oxidase inhibitor within the past 3 weeks; * are nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to take a urine pregnancy test on the day of but prior to study drug administration to rule out pregnancy); * having used any investigational drug and/or participated in any clinical research trial within 30 days of baseline * enlarged prostate * narrow angle glaucoma * use of oxymetazoline or phenylephrine nasal spray or oral decongestant on the day of the study * congenital or idiopathic methemoglobinemia * diabetes mellitus