(107 days)
No
The document describes a traditional dental impression material and its physical properties, with no mention of AI or ML technology.
No
The device is an impression material used to create molds of the oral cavity, which are then used for diagnostic or restorative purposes. It does not directly treat or prevent a disease or condition.
No
This device is an impression material used to create molds of oral structures, not to identify or diagnose a disease or condition. Its purpose is to aid in the production of restorative and prosthetic devices.
No
The device description clearly states it is a two-part Alginate impression system, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Accu-Dent XD impression materials are used to create a physical impression of the oral cavity, which is a direct interaction with the patient's anatomy, not a specimen derived from the body for examination.
- The intended use is for creating physical models and impressions for dental procedures and devices. This is a mechanical and physical process, not a diagnostic test performed on a biological sample.
- The performance studies focus on physical properties of the material. The metrics measured (working time, tear strength, etc.) are related to the material's ability to create an accurate physical impression, not to diagnose a condition or provide information about a patient's health status based on a biological sample.
The device is a dental impression material, which is a medical device used in the process of creating dental prosthetics and models. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
ELW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tropicalgin (K043131), Neocolloid (K981091)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
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 14228 | |
| 800-533-6825 | |
| 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 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. |
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.
4
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 impression
material intended to be placed on
a preformed impression tray and
used to reproduce the structure
of a patient's teeth. It is also
intended to provide models for
study and for production of
restorative prosthetic devices,
such as dental inlays and
dentures.
(Neocolloid) Alginate dental
impression materials that are
intended to be used to make
dental impressions. The resulting
impressions are used to make
plaster models of then teeth. | The AccuDent 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 Models
• Temporary crown & bridge impressions
• Whiting Trays
• Mouth Guards
• Orthodontic Impressions |
|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion The variation is not substantial and is a refinement and clarification of the
predicate's more general statement of indications. | | |
5
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 | |
| Working | ||
| principle | Neocolloid and Tropicalgin were | |
| developed separately. | Accu-Dent XD Tray and Syringe materials | |
| were developed to work together. | ||
| The powder is intended to be mixed | ||
| with water | The powder is intended to be mixed with | |
| water | ||
| 18 gm powder to 36 ml water for | ||
| Tropicalgin | ||
| 18 gm powder to 36 ml water for | ||
| Neocolloid | 24gm gm powder to 44 ml water for Tray | |
| 9gm powder to 21 ml water for Syringe | ||
| The mixed paste is loaded onto a | ||
| preformed perforated impression | ||
| tray and inserted into the mouth. | ||
| While in the mouth, the paste | ||
| polymerizes so when it is removed, it | ||
| leaves an impression of the patitent's | ||
| dentition. | The mixed syringe paste is loaded into a | |
| plastic delivery syringe with specially | ||
| designed application tip and the material is | ||
| dispensed directly onto the oral tissue by | ||
| hand. The mixed tray paste is loaded onto | ||
| a preformed perforated impression tray and | ||
| inserted into the mouth. While in the | ||
| mouth, the paste polymerizes so when it is | ||
| removed, it leaves an impression of the | ||
| patient's dentition. | ||
| Tropicalgin was designed to exhibit a | ||
| chromatic color change as the | ||
| materials set. | Accu-Dent XD also has the chromatic | |
| color change (Tray material only) as the | ||
| materials 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 scent
Neocolloid 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 Blue
Accu-Dent XD Syringe is Orange
Both 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 materials
Load into preformed tray
Insert into mouth and wait til set
Remove from mouth
Disinfect
Pour the impression - dental stone | Mix materials
Load Tray material into preformed tray
Load syringe material into dispensing syringe
Syringe material onto tissue
Insert filled tray into mouth and wait until set
Remove from mouth
Disinfect
Pour 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.
6
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 21563:2013 | |
| Dentistry: Hydrocolloid | |||
| Impression Materials | |||
| Applicable FDA Guidance | Dental Impression Materials | ||
| 1998 | Dental Impression Materials | ||
| 1998 | |||
| Discussion ISO 21563 is a consolidation of 3 standards relating to impression materials | |||
| including ISO 1563:1990 for Alginate impression materials. Under the new standard, the | |||
| alginate materials are now required to be subject to the same tear strength test that has | |||
| been 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 better | |||
| performance 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 | 18gm | |||||
| 36ml | 18gm | |||||
| 36ml | 24gm | |||||
| 44ml | 9gm | |||||
| 21ml | ||||||
| Compressive | ||||||
| Strength | ISO | |||||
| 1563: | ||||||
| 1990 | 1.362 N/mm | ISO | ||||
| 1563:1990 | 1.336 N/mm | .943 N/mm | ||||
| Tear Strength | ISO | |||||
| 21563: | ||||||
| 2013 | 0.647 N/mm | 0.597 N/mm | ISO | |||
| 21563:2013 | ||||||
| 0.38 | ||||||
| N/mm(min) | 0.778 N/mm | 0.504 N/mm | ||||
| Strain in | ||||||
| Compression | ||||||
| Permanent | ||||||
| deformation | ISO | |||||
| 1563: | ||||||
| 1990 | ||||||
| 5.0% - | ||||||
| 20.0% | 11.5% | 10.3% | ISO | |||
| 21563:2013 | ||||||
| 5.0% - | ||||||
| 20.0% | 10.0% | 14.62% |
8
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 from
deformation | ાડળ
1563:
1990
Min.
95.0% | 99% | 99% | ાડભ
21563:2013
Min 95.0% | 95.56% | 97.63% |
|--------------------------------------------------------------------------------------------|---------------------------------------------------|----------|----------|-------------------------------------------|----------|----------|
| Gypsum
Compatibility | ાટેટે
1563:
1990
Line
reprod
50 um | complies | complies | ાડભ
21563:2013
Line reprod
50 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.