(128 days)
Hygedent Alginate Impression Material is irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Hygedent Alginate Impression Material is a dust free alginate impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a homogeneous orange colored powder with a nice mint flavor. The material has exceptional good elastic properties and a high tear-resistance. The impression surface is very smooth, which gives excellent gypsum compatibility.
This document describes the acceptance criteria and the study conducted for the Hygedent Alginate Impression Material.
1. Table of Acceptance Criteria and Reported Device Performance:
The document compares the physical parameters of the proposed device (Hygedent Alginate Impression Material) against a predicate device. While specific "acceptance criteria" for each parameter are not explicitly stated as numerical thresholds, the comparison itself implies that the proposed device must perform comparably to the predicate device.
| Physical Parameters | Proposed Device Performance | Predicate Device Performance | Implied Acceptance Criteria (relative to Predicate) |
|---|---|---|---|
| Appearance | Powder | Powder | Must be Powder |
| Odor | Peppermint | Peppermint | Must be Peppermint |
| Compression strength | 0.75 MPa | 0.7 MPa | Must be similar (0.75 MPa is close to 0.7 MPa) |
| Compatibility with gypsum | 50 μm | 50 μm | Must be 50 μm |
| Recovery from Deformation | 96.50 % | 96 % | Must be similar (96.50% is close to 96%) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" and thus no sample size for it. The performance data presented (in the table above) appears to be from non-clinical testing conducted by the manufacturer. The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective, beyond being generated for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The study did not involve human experts establishing ground truth for a test set. The evaluation was based on physical property measurements against a predicate device and established standards.
4. Adjudication Method for the Test Set:
Not applicable. There was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a material science study, not an AI or diagnostic imaging study involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is an impression material, not a software algorithm that performs diagnostic tasks. The performance evaluation focuses on the material's physical properties.
7. Type of Ground Truth Used:
The "ground truth" for this study was based on:
- Physical property measurements: Direct measurements of the material's characteristics (compression strength, compatibility with gypsum, recovery from deformation).
- Comparison to a predicate device: The predicate device served as a benchmark for "substantially equivalent" performance.
- Compliance with international standards: ISO 1563:1990 and ADA Specification No.18.1992 were used as benchmarks for acceptable performance.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
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510(k) Summary
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| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | 2014 Jan 04. |
| Submitter: | HYGEDENT INC. |
| Add: Daliushu Industrial Zone Xiaotangshan Changping District, 102211, | |
| Beijing, P. R. China | |
| Primary Contact Person: | Peng Wang |
| General Manager | |
| HYGEDENT INC. | |
| Tel: +86-13901284956 | |
| Fax: +86-10-60701780 | |
| Secondary ContactPerson: | Mike Gu |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd. | |
| Tel: (+86)-20-6232 1333 | |
| Fax: (+86) -20-8633 0253 | |
| Device: Trade Name | Hygedent Alginate Impression Material |
| Common/UsualName: | Impression Material |
| Classification Names: | Material, Impression |
| Regulation number: | CFR 872.3660 |
| Product Code: | ELW |
| Predicate Device(s): | K023466 |
| Device Description: | Hygedent Alginate Impression Material is a dust free alginate impressionmaterial with a creamy consistency for general dental practice and fororthodontics. It is presented in the form of a homogeneous orange coloredpowder with a nice mint flavor. The material has exceptional good elasticproperties and a high tear-resistance. The impression surface is verysmooth, which gives excellent gypsum compatibility. |
| Intended Use: | Hygedent Alginate Impression Material is irreversible hydrocolloids fordental impressions used by the dentist to take the anatomical data of thepatient's mouth. The device is intended to provide models for study andfor production of restorative prosthetic devices such as gold inlays and |
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dentures.
Technology:
All the alginates described in the premarket notification application (510k) have the following technological characteristics:
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- Identical mechanism of action
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- Highly similar preparation times
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- Highly similar elastic recovery and accuracy
The physical properties of the proposed device and the predicate device are compared as following:
| Physical Parameters | Proposed device | Predicate device |
|---|---|---|
| Appearance | Powder | Powder |
| Odor | Peppermint | Peppermint |
| Compression strength | 0.75MPa | 0.7 MPa |
| Compatibility with gypsum | 50μm | 50μm |
| Recovery from Deformation | 96.50 % | 96% |
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
Hygedent Alginate Impression Material contacts directly with the oral mucosa. The duration of contact is less than 24 hours. Biocompatibility of the Material complies with ISO 10993-10. The test results demonstrate that the proposed device is biocompatible.
Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalence to the predicate device:
- ・ ISO 1563:1990;
- . ADA Specification No.18.1992;
Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are safe and as effective for their intended use. The subject of this premarket submission, Hygedent Alginate Impression Material, did not require clinical studies to support substantial equivalence.
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Conclusion:
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HYGEDENT INC. considers the Hygedent Alginate Impression Material to be as safe, as effective, and performance is substantially equivalent to the predicate device. .
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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
May 21, 2014
HYGEDENT, Incorporated Ms. Peng Wang General Manager Daliushu Industrial Zone Xiaotangshan, Changping District Beijing 102211 P.R. CHINA
Re: K140074
Trade/Device Name: Hygedent Alginate Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Il Product Code: ELW Dated: February 19, 2014 Received: February 21, 2014
Dear Ms. Wang:
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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Page 2 - Ms. Wang
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/ResourcesforYou/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 yours,
Mary S. Runner -S
Erin I. Keith, M.S. Acting 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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140074 510(k) Number (if known): []
Device Name: Hygedent Alginate Impression Material
Common/usual name: Impression Material
Indications for Use:
Hygedent Alginate Impression Material is irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2014.05.20 11:33:11 -04'00'
§ 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).