SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS

K964179 · S.S. White Mfg., Ltd. · EBF · Jan 9, 1997 · Dental

Device Facts

• Record ID: K964179
• Device Name: SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
• Applicant: S.S. White Mfg., Ltd.
• Product Code: EBF · Dental
• Decision Date: Jan 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Indications for Use

These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.

Device Story

Super-Dent Etching Gel and Micro-Etch Gel are phosphoric acid-based gels used in dental clinics. Applied by dentists to tooth surfaces via syringe and hollow applicator to etch enamel/dentin prior to restoration. Gel formulation provides visibility and viscosity to prevent migration to sensitive oral tissues. Increased viscosity improves adhesion compared to predicate. Washed away with water after etching process. Enhances bonding surface for restorative materials.

Clinical Evidence

No clinical data.

Technological Characteristics

Aqueous gel containing nominal 40% ortho-phosphoric acid. Colored for visibility. High viscosity for localized placement. Delivered via syringe and hollow applicator. Manual application.

Indications for Use

Indicated for dental patients requiring surface etching of tooth material prior to restorative procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Zenith 40% Phosphoric Acid Gel (K890464)

Submission Summary (Full Text)

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SWHITE

SS White Manufacturing

9 Madleaze Estate, Bristol Road, Gloucester, GL1 5SG. England.

Telephone: [phone]. Fax: [phone]

K964179

JAN. 9, 1997

# PREMARKET NOTIFICATION

510(k) SUMMARY

NAME: S.S. White Manufacturing

ADDRESS: Unit 9, Madleaze Estate, Bristol Road, Gloucester, GL1 5SG England

PHONE No: 01452 307171

FAX No.: 01452 307187

CONTACT: Hugh Savell
SS White Group Compliance Manager

DATE PREPARED: 9th October, 1996

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# PREMARKET NOTIFICATION

510(k) SUMMARY (continued)

## TRADE NAMES:
- Super-Dent Etching Gel
- Super-Dent Micro-Etch Gel
- Super-Dent Etching Gel Syringe Tips

## COMMON NAME:
Phosphoric acid etching gel

## CLASSIFICATION NAME:
Dental cement accessory, phosphoric acid etching gel

## EQUIVALENT TO:
Zenith 40% Phosphoric Acid Gel
510(k) No. K890464

## DESCRIPTION:
These materials consist of a gel containing ortho-phosphoric acid.

## INTENDED USE:
These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.

## TECHNOLOGICAL CHARACTERISTICS:
Both devices are aqueous gels containing a nominal 40% ortho-phosphoric acid and delivered directly to the restoration site from a syringe via a hollow applicator. Both devices are coloured for visibility in contrast with tooth material. They are sufficiently viscous to remain where placed and avoid potentially harmful contamination of more sensitive oral tissues. Both devices wash readily from the site when etching is complete.

The subject device is intentionally more viscous than the predicate device to improve adhesion after placement.

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# PREMARKET NOTIFICATION

510(k) SUMMARY (continued)

## NON-CLINICAL DATA:

Non-clinical testing includes tests for pH, acid content, adhesion and water washability.

The tests indicate results for pH and acid content which are comparable within formulation and experimental accuracy.

The test for adhesion indicates better adhesion of the subject device. The device is intentionally more viscous than the predicate device to improve adhesion after placement.

The test for water washability indicates marginally easier washability for the predicate device. This is a direct result of the intentionally increased viscosity (and adhesion) of the subject device. The washability of the subject device is satisfactory on consideration of the method of removal.

## CLINICAL DATA:

There is none applicable

## CONCLUSIONS:

The data summarised above indicates that the subject device is substantially equivalent to the predicate device.

Any differences in performance are a result of improvements designed to render the product safer and more effective in clinical use.