(69 days)
Not Found
Not Found
No
The summary describes a material (thermoplastic resin) used in a fabrication process (injection molding or pressing) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a material used for the fabrication of temporary dental prostheses, it is not a therapeutic device itself.
No
The device is a material (thermoplastic resin) used for fabricating temporary dental prostheses. Its function is to create a physical dental restoration, not to diagnose a condition.
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, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The device is a material (thermoplastic resin) used in a fabrication process (injection molding or pressing). It is not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health status.
IVDs are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical dental restoration.
N/A
Intended Use / Indications for Use
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
Product codes
EHP
Device Description
The Acetal 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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3285 Preformed clasp.
(a)
Identification. A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
INOVATIV, LLC.
KQa2o3a
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:
Inovativ, LLC.
1155 Twin Hills Drive Jefferson, OR 97352
(503)585-4362 (503)585-1188
Bob Bowers Chief Operating Officer
June 10, 2002 Date Summary Prepared:
1
Inovativ Acetal 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 accordance 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: | June 10, 2002 |
9.2 DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | Acetal |
|---|---|
| b. Classification Name: | Preformed Clasp |
| 21 CFR 872.3285 |
9.3 IDENTIFICATION OF PREDICATE DEVICES
The Acetal material is a thermoplastic resin used to prefabricate partial denture clasps. This material is substantially equivalent to the Pressing North America, Inc. material, "Acetal Dental" Acetal resin. This material is commercially available in the United States.
9.4 DEVICE DESCRIPTION
The Acetal 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
Inovativ Acetal Original Premarket 510(K) Notification
9.5 SUBSTANTIAL EQUIVALENCE
This material is substantially equivalent to the Pressing North America, Inc. material, "Acetal Dental" Acetal resin. The fundamental characteristics are similar: the Acetal thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.
9.6 INDICATIONS FOR USE
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
9.7 TECHNOLOGICAL CHARACTERISTICS
A chemical analysis of the Acetal is provided within this submission. Both the Acetal and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality,
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services-URA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-URA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with three curved lines above them. The profiles and lines are arranged to suggest a sense of movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2002
Mr. Robert Bowers Chief Operations Officer Inovativ, LLC 1155 Twin Hills Drive Jefferson, Oregon 97352
Re: K022032
Trade/Device Name: Acetal Regulation Number: 21 CFR 872.3285 Regulation Name: Preformed Clasp Regulatory Class: I Product Code: EHP Dated: June 10, 2002 Received: June 21, 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.
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.
4
Page 2 - Mr. Robert Bowers
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Tim A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Page 1 of 1
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name_ _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
:
Do not write below this line - Continue on another page if needed
and the comments of the comments of the comments of the many of the comments of the comments of the comments of the comments of the contribution of the comments of the contra
Prescription Use سك (Per 21 CFR 801.109) OR
Over the counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
140000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 510(k) Number:_