PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE

K962370 · Challenge Products, Inc. · EJR · Mar 31, 1997 · Dental

Device Facts

Record IDK962370
Device NamePERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
ApplicantChallenge Products, Inc.
Product CodeEJR · Dental
Decision DateMar 31, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.6030
Device ClassClass 1

Intended Use

The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

Device Story

Prophy paste; used by dental professionals; removes materia alba, plaque, and resistant stains from tooth surfaces; applied during routine dental cleaning procedures; aids in oral hygiene maintenance.

Clinical Evidence

No clinical data; safety assessment based on review of 11 MDR records for product code EJR, identifying minimal adverse events related to prophy paste.

Technological Characteristics

Prophy paste formulation; abrasive material for dental cleaning.

Indications for Use

Indicated for dental professionals to remove materia alba, plaque, and resistant stains from tooth surfaces.

Regulatory Classification

Identification

An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} MAR 31 1997 # I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS K962370 ## 1. Name and Address This Summary of Safety and Effectiveness is being submitted by Challenge Products, Inc., Lake Road 54-22 P.O. Box 468, Osage Beach, Missouri 65065. ## 2. Name of the Device The device is generally known as a prophy paste. ## 3. Identification of Predicate Device(s) Challenge Products, Inc. Prophy Paste, FDA control number K940496. ## 4. Description of the Device The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth. ## 5. Intended Use of the Device The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth. ## 6. Comparison of Technological Characteristics The differences between Challenge's new prophy paste and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way. ## 7. Safety Challenge reviewed the 11 MDR records filed with CDRH relating to FDA's product code,"EJR" which were obtained from a CD-ROM database¹. Most of the events occurred as a result from an allergic or adverse reaction to a prophy ¹ The Medical Device Library, IHS Regulatory Products, 15 Inverness Way East, Englewood, CO 80150. 13 {1} jet powder. 3 of the 11 reports were filed for a prophy paste and 1 report was on a patient with a history of allergies. These reports follow. 14
Innolitics
510(k) Summary
Decision Summary
Classification Order
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