AH PLUS ROOT CANAL SEALER

K960548 · Dentsply Intl. · KIF · Apr 26, 1996 · Dental

Device Facts

• Record ID: K960548
• Device Name: AH PLUS ROOT CANAL SEALER
• Applicant: Dentsply Intl.
• Product Code: KIF · Dental
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AH® PLUS™ Root Canal Sealer is used for permanent sealing of root canals following established endodontic procedures.

Device Story

AH® PLUS™ Root Canal Sealer is a two-component (Paste A: epoxy resin; Paste B: amine-containing) root canal sealer. Components are mixed prior to insertion into the root canal by a dentist or endodontist. The material adapts to root canal walls, providing dimensional stability and minimal shrinkage upon setting via an epoxide/amine chemical reaction. Used in conjunction with auxiliary materials like gutta-percha points to provide a permanent seal following endodontic procedures.

Clinical Evidence

Bench testing only. Evaluated via Ames Mutagenicity Test (non-mutagenic), LD50 in rats (>5000 mg/kg), Acute Oral Toxicity (non-toxic), Growth Inhibition Test (non-cytotoxic), guinea pig sensitization (weak sensitizer per ISO 10993-10, non-sensitizer per OECD), and rabbit implantation tests (no macroscopic response, moderate microscopic response). Physical properties meet ISO 6876 and ADA 57 standards.

Technological Characteristics

Two-component epoxy-amine resin paste system. Complies with ISO 6876 and ADA 57 specifications. Biocompatibility testing performed per ISO 10993-10.

Indications for Use

Indicated for permanent sealing of root canals in patients undergoing endodontic procedures.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• AH26® Root Canal Sealer (Pre-1976 Device)

Submission Summary (Full Text)

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K960548

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

NAME & ADDRESS: DENTSPLY International, 570 West College Avenue, York, PA 17404
CONTACT: P. Jeffery Lehn
PHONE: [phone]
FAX: [phone]
DATE PREPARED: April 18, 1996

TRADE OR PROPRIETARY NAME: AH® PLUS™ ROOT CANAL SEALER

COMMON OR USUAL NAME: Root Canal Sealer

CLASSIFICATION NAME: Root Canal Filling Resin 21 CFR, 872.3820

LEGALLY MARKETED DEVICE: AH26® Root Canal Sealer Pre-1976 Device

DEVICE DESCRIPTION: AH® PLUS™ Root Canal Sealer is a two-component paste:paste root canal sealer based on epoxy-amine resin chemistry. This easy-to-mix sealer adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

The final product consists of two components, the epoxy resin paste (Paste A) and the amine-containing paste (Paste B) portions which are mixed prior to insertion into the root canal.

AH® PLUS™ Root Canal Sealer and AH26® Root Canal Sealer are both two-component systems that react via an epoxide/amine chemical reaction to cause setting. They are both used in conjunction with the same auxiliary materials in the root canal (e.g., gutta percha points).

The physical properties of AH® PLUS™ Root Canal Sealer meet or exceed those standards found in ISO Specification 6876 and ADA Specification 57. AH® PLUS™ Root Canal Sealer and AH26® Root Canal Sealer are comparable in setting time, flow, shrinkage, and microleakage physical property values.

INTENDED USE: AH® PLUS™ Root Canal Sealer is used for permanent sealing of root canals following established endodontic procedures. The predicate device, AH26® Root Canal Sealer has the same intended use.

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510(k) SUMMARY (cont'd.)
TRADE NAME: AH® PLUS™ ROOT CANAL SEALER
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TECHNOLOGICAL CHARACTERISTICS: The components of AH® PLUS™ Root Canal Sealer are either found in other DENTSPLY legally marketed predicate devices or their safety is documented in Material Safety Data Sheets.

AH® PLUS™ Root Canal Sealer has undergone extensive pre-clinical testing.

Paste A, the amines contained in Paste B, and the mixed cured sealer were evaluated using the Ames Mutagenicity Test and found to be non-mutagenic.

The resins contained in Paste A were found to have an LD₅₀ in rats of >5000 mg/kg in studies reported in MSDSs. Paste B was evaluated for Acute Oral Toxicity in rats and found to be non-toxic. The mixed cured sealer was evaluated using the Growth Inhibition Test and found to be non-cytotoxic.

The mixed, cured sealer was evaluated in guinea pigs for its sensitization potential and found to be a weak sensitizer according to ISO 10993-10 and a non-sensitizer according to OECD guidelines.

Implantation tests in rabbits on the mixed sealer resulted in no macroscopic visible response and a moderate degree of microscopic response. There was no other evidence of an irritant effect of the sealer.

## CONCLUSION

The results of our testing show that, the fact that AH® PLUS™ Root Canal Sealer has different technological characteristics than the predicate device, does not raise different questions of safety and efficacy.

We believe this is supported by the ingredient toxicity testing, the performance data, and the final product testing of AH® PLUS™ Root Canal Sealer.