(78 days)
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No
The description focuses on the chemical composition and physical properties of a root canal sealer, with no mention of AI or ML.
No.
The device is a sealer used for permanent sealing of root canals, which is a material used in a medical procedure, not a device that itself provides therapy.
No
Explanation: The device is a root canal sealer, which is a therapeutic product used for permanent sealing of root canals, not for diagnosing conditions.
No
The device description clearly states it is a two-component paste based on epoxy-amine resin chemistry, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for permanent sealing of root canals following established endodontic procedures." This describes a procedure performed on the patient's body (specifically, within the root canal), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a two-component paste that is mixed and inserted into the root canal. This is a material used in a therapeutic procedure, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
In summary, the device is a material used in a dental procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
AH® PLUS™ Root Canal Sealer is used for permanent sealing of root canals following established endodontic procedures.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
root canals
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The physical properties of AH® PLUS® Root Ganal Sealer meet or exceed those standards found in ISO Specification 6876 and ADA Specification 57. AH® PIJS® Root Canal Sealer and AH26® Root Canal Sealer are comparable in setting time, flow, shrinkage, and microleakage physical property values.
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 ID50 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AH26® Root Canal Sealer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3820 Root canal filling resin.
(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
DENTSPLY
TSPLY Internation
Wast College Avenue Box 870
510(k) SUMMARY
Page 1 of 2
NAME & ADDRESS: DENTSPLY International, 570 West College Avenue, York, PA 17404 P. Jeffery Lehn CONTACT: (717) 849-4343 (717) 845-7511 FAX: PHONE: DATE PREPARED: April 18, 1996
TRADE OR PROPRIETARY NAME: AH® PLUS™ ROOT CANAL SEALER
Root Canal Sealer COMMON OR USUAL NAME:
21 CFR, 872.3820 CLASSIFICATION NAME: Root Canal Filling Resin
AH26® Root Canal Sealer Pre-1976 Device LEGALLY MARKETED 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.
AN® 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 Ganal Sealer meet or exceed those standards found in ISO Specification 6876 and ADA Specification 57. AH® PIJS® 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.)
Page 2 of 2
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 IDso 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.