JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL

K952614 · Dentsply Intl. · ELW · Aug 13, 1996 · Dental

Device Facts

• Record ID: K952614
• Device Name: JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
• Applicant: Dentsply Intl.
• Product Code: ELW · Dental
• Decision Date: Aug 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

JELTRATE PLUS is used for all routine dental impressions.

Device Story

Jeltrate PLUS is a dustless, fast-setting alginate impression material used by dental professionals to capture dental anatomy. The device functions as a physical impression medium. The subject of this submission is an antimicrobial claim: the material eliminates up to 99% of viable surface microorganisms following a 15-second water rinse of the impression. This feature aims to reduce cross-contamination risks for dental staff handling impressions prior to disinfection or laboratory processing.

Clinical Evidence

Bench testing only. Study results support the claim that the material eliminates up to 99% of viable surface microorganisms after a 15-second water rinse of the impression.

Technological Characteristics

Alginate-based dental impression material. Dustless, fast-setting formulation. No changes in composition, design, or manufacturing compared to predicate K883842.

Indications for Use

Indicated for patients requiring routine dental impressions for clinical procedures.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Jeltrate PLUS Impression Material (K883842)

Submission Summary (Full Text)

{0}

K952614

DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
[phone]
Fax [phone]

AUG 13 1996

COMPLIANCE DEPT. TELEFAX [phone]

August 8, 1996

301-480-3002
TELEFAXED AND
EXPRESS MAIL

Mr. Greg Singleton (HFZ-480)
Food and Drug Administration
Center for Devices and Radiological Health
9200 Corporate Boulevard
Rockville, MD 20850

AMENDMENT #3
K952614, Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material

This letter is in response to your telephone call to me this afternoon.

As you requested, attached is a revised 510(k) SUMMARY for K952614, changing the claim to read:

Jeltrate® PLUS™ eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.

If you have any additional questions, please don't hesitate to contact me. Thank you.

Sincerely,


P. Jeffery Lehn
Associate Director
Corporate Compliance

Attachment

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DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
[phone]
Fax [phone]

510(k) SUMMARY

NAME & ADDRESS: DENTSPLY International, 570 West College Avenue, York, PA 17404
CONTACT: P. Jeffery Lehn
PHONE: [phone]
FAX: [phone]
DATE PREPARED: August 8, 1996

TRADE OR PROPRIETARY NAME: JELTRATE® PLUS™ IMPRESSION MATERIAL

COMMON OR USUAL NAME: Impression Material

CLASSIFICATION NAME: Impression Material, 21 CFR, 872.3660

LEGALLY MARKETED DEVICE: Jeltrate PLUS Impression Material K883842

DESCRIPTION OF DEVICE: JELTRATE PLUS is dust free, fast setting, and helps protect staff from infection due to cross-contamination prior to soaking the impression.

INTENDED USE: JELTRATE PLUS is used for all routine dental impressions.

TECHNOLOGICAL CHARACTERISTICS: There has been no change in composition, design, material, packaging, function or manufacture of Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material (K883842). This submission represents only an additional claim.

We believe the conclusions of the study conducted support the additional claim that JELTRATE PLUS eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.