(107 days)
The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications:
- Complete and partial denture impressions ●
- Opposing models for fixed and removable prosthesis ●
- o Study Model
- Temporary crown & Bridge impressions
- Whitening Trays ●
- Mouth Guards ●
- Orthodontic Impressions o
Accu-Dent XD is a two-part Alginate impression system 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 impressions models for study and for production of restorative prosthetic devices, such as full and partial dentures.
This document describes the premarket notification (510(k)) for the Accu-Dent® XD impression material. It is a Class II medical device used to create detailed impressions of the oral cavity. The submission aims to demonstrate substantial equivalence to predicate devices, Tropicalgin (K043131) and Neocolloid (K981091) by Zhermack sPA.
Below is a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details physical properties for the Accu-Dent® XD and its predicate devices, aligning them with relevant ISO standards.
| Characteristic | Predicate Device (Tropicalgin) | Predicate Device (Neocolloid) | Acceptance Criteria (Standard) | Accu-Dent® XD (Tray) | Accu-Dent® XD (Syringe) | Accu-Dent® XD Performance (Tray) | Accu-Dent® XD Performance (Syringe) |
|---|---|---|---|---|---|---|---|
| Mixing Time | 45" | 45" | - | 45" | 45" | Meets | Meets |
| Working Time | 1'35" | 2'00" | - | 1'15" | 2'00" | Comparable | Comparable |
| Setting Time | 2'35" | 3'30" | - | 2'30" | 3'30" | Comparable | Comparable |
| Time in Mouth | 1'00" | 1'30" | - | 30" | 45" | Shorter | Shorter |
| Ratio Powder/Water | 18gm/36ml | 18gm/36ml | - | 24gm/44ml | 9gm/21ml | Different | Different |
| Compressive Strength | 1.362 N/mm (ISO 1563:1990) | 1.336 N/mm (ISO 1563:1990) | ISO 21563:2013 (no direct AC) | .943 N/mm | N/A | Result provided | Not applicable (Syringe material) |
| Tear Strength | 0.647 N/mm (ISO 21563:2013) | 0.597 N/mm (ISO 21563:2013) | ISO 21563:2013: 0.38 N/mm(min) | 0.778 N/mm | 0.504 N/mm | Meets (above min) | Meets (above min) |
| Strain in Compression | 11.5% (ISO 1563:1990: 5.0-20.0%) | 10.3% (ISO 1563:1990: 5.0-20.0%) | ISO 21563:2013: 5.0% - 20.0% | 10.0% | 14.62% | Meets | Meets |
| Recovery from Deformation | 99% (ISO 1563:1990: Min. 95.0%) | 99% (ISO 1563:1990: Min. 95.0%) | ISO 21563:2013: Min 95.0% | 95.56% | 97.63% | Meets (within criteria) | Meets (within criteria) |
| Gypsum Compatibility | complies (ISO 1563:1990: 50 um) | complies (ISO 1563:1990: 50 um) | ISO 21563:2013: Line reprod 50 µm | Complies | Complies | Meets | Meets |
Note: The discussion section notes that the "primary change from the predicate is the powder/water ratio for the mixed alginate. This change impacts the physical properties, but not in a significant manner. The most notable change is the difference in the Recovery from deformation results. Although lower, the result remains within the acceptance criteria of the ISO 21563 and ISO 1563 of minimum 95%." The conclusion states that "The above data and analysis demonstrates that Accu-Dent XD is substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each physical property test. However, it indicates these tests were conducted to demonstrate compliance with ISO standards (ISO 21563:2013 and ISO 1563:1990) and FDA Guidance.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective, but it is implied to be laboratory testing conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The ground truth for these types of dental impression materials is typically established through adherence to standardized laboratory test methods and compliance with ISO standards, not through expert consensus in the clinical sense.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically relevant for studies involving human interpretation or clinical endpoints. This document focuses on the physical and technological characteristics of a material tested against laboratory standards. Therefore, an adjudication method is not applicable in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not mention any MRMC comparative effectiveness study. The comparison is based on physical properties tested against ISO standards and existing predicate devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is an impression material, not a software algorithm or an AI-based system. Its performance is evaluated through material science and physical property testing.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Accu-Dent® XD is based on standardized laboratory testing and compliance with recognized international standards (ISO 21563:2013 and ISO 1563:1990) for dental impression materials. These standards define the acceptable range for various physical properties such as tear strength, strain in compression, recovery from deformation, and gypsum compatibility.
8. The Sample Size for the Training Set
Not applicable. This device is a material, not an AI or algorithm that requires a "training set" in the machine learning sense. The development of the material would involve various formulations and iterative testing, but this is not referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The development process for the Accu-Dent® XD impression material would involve R&D and quality control testing, ensuring the material meets desired performance characteristics, but not by establishing ground truth for a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2015
Ivoclar Vivadent, Inc. Ms. Donna Marie Hartnett Director, OA/Regulatory Affairs 175 Pineview Drive Amherst. New York 14228
Re: K143575
Trade/Device Name: Accu-Dent® XD Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: II Product Code: ELW Dated: January 2, 2015 Received: January 5, 2015
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K143575
Device Name: Accu-Dent® XD
Indications For Use:
The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications:
- Complete and partial denture impressions ●
- Opposing models for fixed and removable prosthesis ●
- o Study Model
- Temporary crown & Bridge impressions
- Whitening Trays ●
- Mouth Guards ●
- Orthodontic Impressions o
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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Accu-Dent XD
Revised April 3. 2015
Image /page/3/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "Ivoclar" in a lighter blue and "Vivadent" in a darker blue. Above the name are several green and blue squares and circles. Below the name is the company's slogan, "passion vision innovation," in a smaller, red font.
Revised April 3, 2015
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent, Inc.175 Pineview Drive, Amherst, NY 14228800-533-6825 |
| Date Prepared: | April 3, 2015 |
| Proprietary Name: | Accu-Dent ® XD |
| Classification Name: | Material, Impression (872.3660)(Classification Code ELW) |
| Predicate Device: | Tropicalgin (K043131) & Neocolloid (K981091) by Zhermack sPA |
| Device Description: | Accu-Dent XD is a two-part Alginate impression system intendedto be placed on a preformed impression tray and used toreproduce the structure of a patient's teeth and gums. The deviceis intended to provide impressions models for study and forproduction of restorative prosthetic devices, such as full andpartial dentures. |
vivade
passion vision inr#### Intended Use:
The Accu-Dent XD impression materials are recommended for use to create highly detailed impressions of the hard and soft tissues of the oral cavity including the following list of indications:
- Complete and partial denture impressions
- . Opposing models for fixed and removable prosthesis
- Study Model ●
- . Temporary crown & Bridge impressions
- . Whitening Trays
- . Mouth Guards
- Orthodontic Impressions ●
Comparison to Predicate: The predicate device to which Accu-Dent XD has been compared is Tropicalgin (K043131) & Neocolloid (K981091) by Zhermack sPA . Accu-Dent XD consists of a tray material (comparable to Tropicalgin) and a Syringe material (comparable to Neocolloid) which, when used together are intended to take impressions of the oral cavity. The materials have been compared based on physical properties for working time, strain in compression, recovery from deformation, tear strength, gypsum compatibility and detail reproduction. Accu-Dent XD materials have been determined to be substantially equivalent to the predicate device.
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Accu-Dent XD
Revised April 3, 2015
Image /page/4/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "Ivoclar" in a smaller, lighter blue font above "Vivadent" in a larger, darker blue font. Above the company name is a semi-circular arrangement of green and blue squares, with the green squares on the left side and the blue squares on the right side.
passion vision innovation
| Indications | (Tropicalgin) Dental impressionmaterial intended to be placed ona preformed impression tray andused to reproduce the structureof a patient's teeth. It is alsointended to provide models forstudy and for production ofrestorative prosthetic devices,such as dental inlays anddentures.(Neocolloid) Alginate dentalimpression materials that areintended to be used to makedental impressions. The resultingimpressions are used to makeplaster models of then teeth. | The AccuDent XD impression materialsare recommended for use to createhighly detailed impressions of the hardand soft tissues of the oral cavityincluding the following list of indications:• Complete and partial dentureimpressions• Opposing models for fixed andremovable prosthesis• Study Models• Temporary crown & bridge impressions• Whiting Trays• Mouth Guards• Orthodontic Impressions |
|---|---|---|
| Discussion The variation is not substantial and is a refinement and clarification of thepredicate's more general statement of indications. |
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Accu-Dent XD
Revised April 3, 2015
Image /page/5/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar Vivadent" in a sans-serif font. Above the words are a series of green and blue dots and squares arranged in an arc. The dots are green and the squares are blue. The logo is simple and modern.
passion vision innovation
| Technology | passion vision inn | |
|---|---|---|
| Predicate device | Accu-Dent XD | |
| Workingprinciple | Neocolloid and Tropicalgin weredeveloped separately. | Accu-Dent XD Tray and Syringe materialswere developed to work together. |
| The powder is intended to be mixedwith water | The powder is intended to be mixed withwater | |
| 18 gm powder to 36 ml water forTropicalgin18 gm powder to 36 ml water forNeocolloid | 24gm gm powder to 44 ml water for Tray9gm powder to 21 ml water for Syringe | |
| The mixed paste is loaded onto apreformed perforated impressiontray and inserted into the mouth.While in the mouth, the pastepolymerizes so when it is removed, itleaves an impression of the patitent'sdentition. | The mixed syringe paste is loaded into aplastic delivery syringe with speciallydesigned application tip and the material isdispensed directly onto the oral tissue byhand. The mixed tray paste is loaded ontoa preformed perforated impression tray andinserted into the mouth. While in themouth, the paste polymerizes so when it isremoved, it leaves an impression of thepatient's dentition. | |
| Tropicalgin was designed to exhibit achromatic color change as thematerials set. | Accu-Dent XD also has the chromaticcolor change (Tray material only) as thematerials set. | |
| Discussion: The change in powder/water ratio has a minor impact on the physical properties | ||
| Delivery forms | Neocolloid and Tropicalgin are delivered in bulk bags (500g and 453g respectively) which are scooped out by the user using a measuring spoon.Tropicalgin is Yellow and has a Mango scentNeocolloid is Orange and has an herbal scent | Accu-Dent XD Tray and Syringe Powers are delivered in single dose sealed pouches, 12 packages per box.Accu-Dent XD Tray is BlueAccu-Dent XD Syringe is OrangeBoth materials will have a mild mint scent |
| Discussion: | Variations in color and scent play no active role in the performance of the materials.The new pre-dosed pouches are similar to the existing Accu-Dent materials, which have been on the market since before 1976. The packaging processes have been validated to assure adherence to the dosing specification | |
| Storage conditions | 5-27 °C/41-80 °F for all items.3 year shelf life | 5-27 °C/41-80 °F for all items.3-year shelf life |
| Discussion: | No difference | |
| Principles of operation | Mix materialsLoad into preformed trayInsert into mouth and wait til setRemove from mouthDisinfectPour the impression - dental stone | Mix materialsLoad Tray material into preformed trayLoad syringe material into dispensing syringeSyringe material onto tissueInsert filled tray into mouth and wait until setRemove from mouthDisinfectPour the impression - dental stone |
of the device which is discussed below. The two-step clinical procedure has only impact on the finished impression. The color contrast provides for improved impression reading.
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Accu-Dent XD
Revised April 3, 2015
Image /page/6/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "ivoclar vivadent" in a bold, sans-serif font. Above the words are a series of green and blue dots and squares. Below the words is the tagline "passion vision innovation" in a smaller, sans-serif font.
Discussion: No variation except that the Tray and Syringe materials are intended to be used together. The predicate materials were intended to be used alone. The tray and syringe materials have been tested to work together. Once inserted into the mouth, they adhere together and pose no additional safety or efficacy issues.
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510(K) SUMMARY Accu-Dent XD
Revised April 3, 2015
Image /page/7/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized blue font, with the words "passion vision innovation" written in a smaller font below. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape. The logo is simple and modern, and it conveys a sense of innovation and professionalism.
Technological Characteristics:
| Conformity to product-specific Standard | Predicate Device | Accu-Dent XD | |
|---|---|---|---|
| Applicable standard | ADA Spec 18/ ISO 1563 | ISO 21563:2013Dentistry: HydrocolloidImpression Materials | |
| Applicable FDA Guidance | Dental Impression Materials1998 | Dental Impression Materials1998 | |
| Discussion ISO 21563 is a consolidation of 3 standards relating to impression materialsincluding ISO 1563:1990 for Alginate impression materials. Under the new standard, thealginate materials are now required to be subject to the same tear strength test that hasbeen in effect for the agar hydrocolloid impression materials (ISO 1564 and ISO 13716)instead of being subject to a compressive strength. This is understood to be a betterperformance measure. |
| Predicate Device | Accu-Dent XD | |||||
|---|---|---|---|---|---|---|
| Characteristic | Troplicalgin | Neocolloid | Tray | Syringe | ||
| Mixing Time | 45" | 45" | 45" | 45" | ||
| Working Time | 1'35" | 2'00" | 1'15" | 2'00" | ||
| Setting Time | 2'35" | 3'30" | 2'30" | 3'30" | ||
| Time in Mouth | 1'00" | 1'30" | 30" | 45" | ||
| Ratio Powder/Water | 18gm36ml | 18gm36ml | 24gm44ml | 9gm21ml | ||
| CompressiveStrength | ISO1563:1990 | 1.362 N/mm | ISO1563:1990 | 1.336 N/mm | .943 N/mm | |
| Tear Strength | ISO21563:2013 | 0.647 N/mm | 0.597 N/mm | ISO21563:20130.38N/mm(min) | 0.778 N/mm | 0.504 N/mm |
| Strain inCompressionPermanentdeformation | ISO1563:19905.0% -20.0% | 11.5% | 10.3% | ISO21563:20135.0% -20.0% | 10.0% | 14.62% |
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Accu-Dent XD
Revised April 3, 2015
Image /page/8/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in two lines, with "Ivoclar" in a larger, bold blue font above "Vivadent" in a similar blue font. Above the company name is a semi-circular arrangement of green and blue dots and squares. Below the company name is the company slogan "passion vision innovation".
passion vision innovation
| Recovery fromdeformation | ાડળ1563:1990Min.95.0% | 99% | 99% | ાડભ21563:2013Min 95.0% | 95.56% | 97.63% |
|---|---|---|---|---|---|---|
| GypsumCompatibility | ાટેટે1563:1990Linereprod50 um | complies | complies | ાડભ21563:2013Line reprod50 µm | Complies | complies |
| Discussion: The primary change from the predicate is the powder/water ratio for the mixed |
alginate. This change impacts the physical properties, but not in a significant manner. The most notable change is the difference in the Recovery from deformation results. Although lower, the result remains within the acceptance criteria of the ISO 21563 and ISO 1563 of minimum 95%. Therefore, there is no expectation that the clinical outcome of the impression or the ultimate restoration will be affected.
Guidance Document: This submission follow the requirements set out in FDA Guidance Document entitled Dental Impression Materials - Premarket Notification dated August 17, 1998.
CONCLUSION: The above data and analysis demonstrates that Accu-Dent XD is substantially equivalent to the predicate device.
§ 872.3660 Impression material.
(a)
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.(b)
Classification. Class II (Special Controls).