Who is the manufacturer of KALGINATE IMPRESSION MATERIAL?

Teledyne Water Pik filed the 510(k) submission for KALGINATE IMPRESSION MATERIAL (K970594).

What is the FDA product code for KALGINATE IMPRESSION MATERIAL?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for KALGINATE IMPRESSION MATERIAL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KALGINATE IMPRESSION MATERIAL?

Kalginate ® Impression Material (preamendment device).

Who can help prepare an FDA 510(k) submission like KALGINATE IMPRESSION MATERIAL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KALGINATE IMPRESSION MATERIAL

K970594 · Teledyne Water Pik · ELW · Mar 31, 1997 · Dental

Device Facts

Record ID	K970594
Device Name	KALGINATE IMPRESSION MATERIAL
Applicant	Teledyne Water Pik
Product Code	ELW · Dental
Decision Date	Mar 31, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Intended Use

The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient’s teeth and oral tissues.

Device Story

Powdered alginate-based material; mixed with water to form elastic gel; placed in oral cavity to capture impressions of teeth and oral tissues; used by dental professionals in clinical settings; provides physical mold for dental restorations or diagnostic models.

Clinical Evidence

Bench testing only. Accelerated shelf-life testing (3 months at 23°C and 40°C) demonstrated stability equivalent to the original formulation. Biocompatibility confirmed via hamster cheek pouch mucosal irritation histopathology study, showing the new pigment formulation is non-irritating.

Technological Characteristics

Powdered alginate impression material; contains alginate as primary gel-forming agent; modified with Red Pigment #38. Physical form: powder for aqueous mixing. Sterilization: not applicable (non-sterile).

Indications for Use

Indicated for obtaining impressions of teeth and oral tissues in patients requiring dental impressions.

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

Kalginate ® Impression Material (preamendment device)

Related Devices

K970129 — TULIP · Richard Ting · Aug 18, 1997
K991489 — ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) · Harry J. Bosworth Co. · Jul 15, 1999
K965083 — SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET · S.S. White Mfg., Ltd. · Apr 4, 1997
K022653 — ELITE MONOPHASE · Zhermack S.P.A. · Oct 28, 2002
K160441 — Identic and KromaFaze Alginate Dental Impression Materials · Kerr Corporation · Jun 30, 2016

Submission Summary (Full Text)

{0} K970594 # MAR 31 1997 ## Kalginate ® 510(K) SUMMARY ### 1. Name and Address of Applicant Teledyne Water Pik 1730 East Prospect Road Fort Collins, CO 80553-0001 **Contact Person** Michael J. Ryan **Telephone** _________________________ **FAX** (970) 221-8252 (970) 221-8662 Prepared on 7 Feb 1997 ### 2. Name of the Device **Classification Name** - Dental Impression Material. **Common Name** - Alginate Impression Material. **Trade Name** - Kalginate ® Impression Material. ### 3. Legally Marketed Device for Substantial Equivalence Determination The Company’s Kalginate ® Impression Material, a preamendment device. ### 4. Description of the Device Kalginate ® is a powdered material, that is mixed with water and placed in the patient’s oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patient’s teeth and oral tissues. ### 5. Intended use of the device The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient’s teeth and oral tissues. {1} 8 ## 6. Material/Technological Characteristics The color pigment material for the Company’s Kalginate ® Impression Material, Valencia Orange, is changed to Red Pigment # 38. A specification sheet and a Material Safety Data Sheet are enclosed. ## 7. Performance data ### Performance Accelerated shelf life testing was conducted on a batch of the new Kalginate ® Impression Material. The batch was mixed and processed using Research and Development equipment. Test samples from the batch were aged for 3 months at 23° and 40° C. The elevated temperature represents a 2 year shelf life. A summary of the tests and the results is discussed in Appendix 4. The results show no stability difference between the new and old Kalginate ® Impression Material formulations. ### Biocompatibility Test results from a cheek Pouch Mucosal Irritation Histopathology Study indicates that the Kalginate ® formulation with the Red Pigment #38 is non-irritating to the cheek pouch mucosa of hamsters.