(88 days)
Not Found
No
The summary describes a material (thermoplastic resin) and its intended use in fabrication processes (injection molding, pressing). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as a material (thermoplastic resin) used for fabricating temporary dental prostheses. It is not intended to treat, mitigate, or prevent a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is intended for the fabrication of temporary dental prostheses, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a thermoplastic resin material used to fabricate dental prostheses, 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 the fabrication of temporary dental prostheses. This is a manufacturing process for a medical device that will be used in the body (or in the mouth, which is considered part of the body for medical device classification).
- Device Description: The device is a material (thermoplastic resin) used in a fabrication process (injection molding or pressing). It is not a test or assay performed on a sample taken from the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, this device is a material used to create a dental prosthesis, which is a medical device, but the material itself and its intended use do not fall under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.
Product codes
EBG
Device Description
The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
"Dent-Temp Acrylic"
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
MAR 2 1 2003
INOVATIV, LLC.
KO24282
1155 Twin Hills Drive Jefferson, OR. 97352 Phone: 503-585-4362 Fax: 503-585-1188
510 (K) Summary
Submitter Name:
Submitter Address:
Submitter Telephone: Submitter Facsimile:
Contact Person:
Date Summary Prepared:
Inovativ, LLC.
1155 Twin Hills Drive Jefferson, OR 97352
(503)585-4362 (503)585-1188
Bob Bowers Chief Operating Officer
November 18, 2002
1
Iı ovativ Acrylic Original Premarket 510(K) Notification
SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(K) summary of safety and effectiveness information is being submitted in a :cordance with the requirements of SMDA 1990 and 21 CFR.807.92.
9 1 SUBMITTER INFORMATION
| a. Company Name: | Inovativ, LLC. |
|---|---|
| b. Company Address: | 1155 Twin Hills Drive |
| Jefferson, OR 97352 | |
| c. Company Telephone: | |
| Company Facsimile: | (503)585-4362 |
| (503)585-1188 | |
| d. Contact Person: | Bob Bowers |
| Chief Operating Officer | |
| e. Date Summary Prepared: | November 18, 2002 |
| 9.2 DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | Acrylic |
b. Classification Name:
Temporary Crown and Bridge Resin 21 CFR 872.3770
5.3 IDI:NTIFICATION OF PREDICATE DEVICES
The Acrylic material is a thermoplastic resin used to prefabricate partial denture clasps, temporary crowns and bridges. This material is substantially equivalent to the Health-Dent International, Inc. "Dent-Temp Acrylic". This material is commercially available in the United States.
1.4 DEVICE DESCRIPTION
The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
2
I 10vativ Acrylic ( )riginal Premarket 510(K) Notification
5.5 SUBSTANTIAL EQUIVALENCE
The Acrylic thermoplastic Acrylic resin is substantially equivalent to the Health-Dent International, Inc. "Dent-Temp Acrylic resin. The fundamental characteristics are similar: the Acrylic thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.
1.6 INDICATIONS FOR USE
The Acrylic is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Acrylic resin.
9.7 TECHNOLOGICAL CHARACTERISTICS
Chemical composition and properties of the Acrylic is provided within this submission. Both the Acrylic and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
Mr. Robert Bowers Chief Operating Officer Inovativ. LLC 1155 Twin Hills Drive Jefferson, Oregon 97352
Re: K024282
Trade/Device Name: Acrylic Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: November 18, 2002 Received: December 23, 2002
Dear Mr. Bowers:
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.
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 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.
4
Page 2 - Mr. Bowers
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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner, DDS, M Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Inovativ Acrylic Original Premarket 510(K) Notification
SECTION 8. 510(K) STATEMENT OF INDICATIONS FOR USE
The 501(K) statement of indications for use for this device is being submitted in accordance with the requirements or 21 CFR 807.87.
8.1 STATEMENT OF INDICATIONS FOR USE.
Indications for Use
510(k) Number
Device Name
Indications for use:
The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.
Do not write below this line - Continue on another page if needed
l'rescription Use (Per 21 CFR 801.109)
OR
Over the counter
(Optional Format 1-2-96)
Kein Muluy for A CR
8-1
ision of Anesthesiology, General Hospital. Infection Control. De
510(k) Number. K024282