(56 days)
Not Found
No
The summary describes a material used for fabrication and its physical properties, with no mention of AI/ML or related concepts.
No
The device is a material used for fabricating dental appliances, not a device that directly provides therapy or treatment.
No.
The device is a material used for fabricating dental appliances like dentures, splints, and night guards, not for diagnosing medical conditions.
No
The device description clearly states it is a "flexible thermoplastics resin," which is a physical material, 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 fabricating dental appliances (dentures, splints, night guards). This is a manufacturing process for a medical device that will be used in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a material used for fabrication, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
Therefore, the Flexo Dental Resin Material is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Product codes (comma separated list FDA assigned to the subject device)
EBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device.
The cytotoxic and biocompatible test has been performed (Non-cytotoxic).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
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.
3
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
4
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.