(79 days)
Not Found
Not Found
No
The provided text describes a dental impression material and does not mention any AI or ML components.
No
The device is described for "routine impressions" for "denture dentition construction, orthodontics, study models," which are diagnostic or procedural purposes, not therapeutic.
No
The device, named Plastalgin, is used for taking routine impressions for procedures like denture construction, orthodontics, and study models. It is a material used as part of a treatment or for modeling purposes, not for diagnosing conditions or diseases.
No
The intended use describes a material (Plastalgin) used for dental impressions, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes taking impressions of teeth and oral structures for purposes like creating dentures, orthodontic appliances, and study models. This is a physical process of capturing a mold, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: While the description is "Not Found," the intended use clearly points to a material used for physical impressions.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on laboratory testing.
Therefore, Plastalgin and Plastalgin Ortho are materials used for dental impressions, which are considered medical devices but not IVDs.
N/A
Intended Use / Indications for Use
Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions).
Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).
Product codes
ELW
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/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 circumference of the circle. Inside the circle is a stylized image of an eagle or other bird, with three lines representing the wings and head of the bird.
Public Health Service
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEPTODONT C/O Mr. Wayne H. Matelski, Esq. Counsel for Septodont Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036-5339
Re: K032708
Trade/Device Name: Plastalgin and Plastalgin Ortho Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 13, 2003 Received: November 14, 2003
Dear Mr. Matelski:
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.
1
Page 2 - Mr. Wayne H. Matelski, Esq.
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. 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) you may obtain. 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,
Signature
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
2
Indications for Use
510(k) Number (if known): K032708
Device Name: Plastalgin and Plastalgin Ortho
Indications For Use:
Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions).
Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).
Prescription Use _ ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suse Burns
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KOBOZOR 510(k) Number: _