SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
K965083 · S.S. White Mfg., Ltd. · ELW · Apr 4, 1997 · Dental
Device Facts
| Record ID | K965083 |
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| Device Name | SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET |
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| Applicant | S.S. White Mfg., Ltd. |
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| Product Code | ELW · Dental |
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| Decision Date | Apr 4, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 872.3660 |
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| Device Class | Class 2 |
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Intended Use
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.
Device Story
Powder-based alginate impression material; mixed with water to form setting gel; applied to oral tissues via rigid tray; captures anatomical detail of oral tissues; used by dental professionals in clinical settings; set material removed from mouth; used to create dental plaster/stone models; facilitates design/fitting of orthodontic prostheses; improved setting time and compressive strength enhance patient comfort and handling durability.
Clinical Evidence
No clinical data. Bench testing performed in accordance with ISO 1563:1990, evaluating working time, setting characteristics, strength, flexibility, gypsum compatibility, and pH.
Technological Characteristics
Powder-based alginate; sets via reaction between alginate and calcium ions to form insoluble calcium alginate; compatible with dental plaster and stone; tested per ISO 1563:1990.
Indications for Use
Indicated for patients requiring dental impressions for orthodontic prostheses and study models.
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
- Dental Alginate Impression Material (K883842)
Related Devices
- K970129 — TULIP · Richard Ting · Aug 18, 1997
- K970594 — KALGINATE IMPRESSION MATERIAL · Teledyne Water Pik · Mar 31, 1997
- K020242 — EMULATE FAST SET AND EMULATE REGULAR SET · Cavex Holland BV · Apr 17, 2002
- K160441 — Identic and KromaFaze Alginate Dental Impression Materials · Kerr Corporation · Jun 30, 2016
- K052455 — IMPRESSIX · Cavex Holland BV · Nov 23, 2005
Submission Summary (Full Text)
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K965083
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# PREMARKET NOTIFICATION
510(k) SUMMARY (continued)
## TRADE NAMES:
- Super-Dent Alginate, Normal set
- Super-Dent Alginate, Fast set
- Super-Dent Super DeLuxe Dustless Alginate, Normal set
- Super-Dent Super DeLuxe Dustless Alginate, Fast set
## COMMON NAME:
Alginate impression material
## CLASSIFICATION NAME:
Material, All, Impression
## EQUIVALENT TO:
Dental Alginate Impression Material; 510(k) number K883842
Marketed by Dentsply as JELTRATE in fast and regular set versions
## DESCRIPTION:
These materials consist of powders which, when mixed with water, form a setting gel suitable for taking impressions of oral tissues.
## INTENDED USE:
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.
## TECHNOLOGICAL CHARACTERISTICS:
Both materials are powders which, when mixed with water, create a setting gel which is applied to the oral tissues in a rigid tray to create an impression of such tissues. The materials set after mixing by virtue of the reaction between an alginate material and calcium ions to form insoluble calcium alginate. The set materials are compatible with oral tissues and the set is chemically controlled in the interests of patient comfort. The set materials are sufficiently flexible to remove from the mouth readily yet strong enough to withstand subsequent handling. Both materials are compatible with dental plaster and stone model materials.
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WHITE
PAGE 22 OF 33
# PREMARKET NOTIFICATION
510(k) SUMMARY (continued)
## NON-CLINICAL DATA:
Non-clinical tests are in accordance with ISO 1563:1990 and include tests for working time, setting characteristics, strength, flexibility, compatibility with gypsum casting materials and pH.
In all the above tests the subject product is at least comparable to the predicate product.
The subject material is faster setting and stronger when set. Both these enhanced attributes are clear advantages in clinical use.
## 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 result in improvements which reduce the setting time in the interests of patient comfort and increase the compressive strength improving the resistance to damage in handling of the impression.
