(56 days)
Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances.
The provided text describes the Flexo Dental Resin Material, an injection moldable, flexible thermoplastic resin used for fabricating removable dental appliances. The submission focuses on demonstrating substantial equivalence to a predicate device, Lucitone FRS Flexibel Dental Resin, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or complex performance studies.
Therefore, many of the requested elements for a study design and acceptance criteria related to AI/algorithm performance are not applicable here.
Here's an analysis based on the provided information, addressing the relevant points and noting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical properties equivalent to predicate device | "Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device." |
| Biocompatibility (Non-cytotoxic) | "The cytotoxic and biocompatible test has been performed(Non-cytotoxic)." |
| Similarity in composition to predicate device | "similarity in composition of Flexo Dental Resin Material to the predicate device" |
| Suitable for intended use: fabrication of partial or full removable dentures, occlusal splints, and night guards | Implied by substantial equivalence to a legally marketed device for these uses. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a test set of data for an AI/algorithm. The "testing" refers to physical property testing and biocompatibility testing of the material itself. The text does not provide specific sample sizes for these material tests, nor does it detail their provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a material science submission, not an AI/algorithm-based diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established standards for material properties and biocompatibility.
- Physical Properties: Likely established through standardized ASTM or ISO testing methods for dental resins. The comparison is against the predicate device's known performance.
- Biocompatibility: Established through standardized in vitro (e.g., cytotoxicity) testing methods.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study (Implied):
The "study" presented here is essentially a substantial equivalence demonstration based on in vitro material property testing and biocompatibility testing, compared against a predicate device.
- Acceptance Criteria Focus: The primary acceptance criterion is that the Flexo Dental Resin Material's physical properties and biocompatibility are equal or similar enough to the legally marketed predicate device (Lucitone FRS Flexibel Dental Resin) to demonstrate it is safe and effective for its intended uses. The composition is also a key factor in this comparison.
- Evidence Provided:
- Physical Property Testing: Stated that "Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device." No specific measurements or methodology are detailed in this summary.
- Biocompatibility Testing: Stated that "The cytotoxic and biocompatible test has been performed (Non-cytotoxic)." Again, details of the test are not provided.
- Compositional Similarity: The submission highlights the "similarity in composition" to the predicate device.
- Conclusion: Based on these comparisons, the ACI Flexo Dental Resin Material is considered substantially equivalent to the Lucitone FRS Flexible Dental Resin in design, material, and function.
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21.0 510(K) SUMMARY
20.1 SUBMITTER INFORMATION
Submitter Name: Address and Telephone Number
JUL 26 2006
ACI. Inc. 5830 Woodson. Ste3. Mission, KS 66202 Tel:(913) 220-2045 Fax:(775) 806-5580
Contact Person:
Charles Lee President
Date Summary Prepared:
May 2006
20.2 DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Flexo Dental Resin Material |
|---|---|
| Classification: | Denture relining, repairing or rebasing resin 872.3760 |
20.3 IDENTIFICATION OF PREDICATE DEVICES
Flexo Dental Resin Material is substantially equivalent to Lucitone FRS Flexibel Dental Resin, K992956, by Dentsply International.
20.4 DEVICE DESCRIPTION
The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances. Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device.
20.5 SUBSTANTIAL EQUIVALENCE
The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances. The Flexo Dental Resin Material is substantially equivalent to other injection moldable material currently in commercial distribution such as Lucitone FRS Flexibel Dental Resin and Valplast Resin Material. For the purpose of this 510K, the Flexo Dental Resin Material will be shown to be substantially equivalent to the Lucitone FRS Flexibel Dental Resin , K992956, by Dentsply International.
20.6 INTENDED USE:
Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
20.7 TECHNOLOGICAL CHARACTERISTICS
All of the components found in Flexo Dental Resin Material have been used in legally marketed device or have been found to be safe for dental use. The cytotoxic and biocompatible test has been performed(Non-cytotoxic).
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We believe that the similarity in composition of Flexo Dental Resin Material to the predicate device, the performance data, and the results of biocompatibility testing support the safety and effectiveness of Flexo Dental Resin Material for the indicate uses.
CONCLUSION
The ACI Flexo Dental Resin Material is considered to be substantially equivalent in design, material and function to the Lucitone FRS Flexible Dental Resin.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Mr. Charles Lee President ACI, Incorporated 5830 Woodson, Ste. 3 Mission, Kansas 66202
Re: K061501
Trade/Device Name: Flexo Dental Resin Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: May 30, 2006 Received: June 07, 2006
Dear Mr. Lee:
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 indives for use stated in the enclosure) to legally marketed predicate devices marketed in interstate comments re 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 Cosmain Act (Act) that do not require approval of a premarket approval application (PMA). You max. 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 text rate manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your revise an he found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA mee publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Charles Lee
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN):
DEVICE NAME: Flexo Dental Resin Material
INDICATION FOR USE:
Flexo Dental Resin Material is intended to fabricate partial or full removable dentures, as well as occlusal splints and night guards.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
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ACI, Inc.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.