(94 days)
KID152431, K071987
Not Found
No
The description focuses on the chemical composition and function of a gel, with no mention of AI or ML technologies.
No.
The device is a gel that blocks oxygen and accelerates polymerization of dental restorative materials, acting as an adjunct to the restoration process rather than directly treating a disease or condition.
No
The device, Pulpdent OX-OUT, is described as a gel used to block oxygen and accelerate polymerization of dental restorative materials, preventing an oxygen inhibited layer and improving setting. Its intended use is for cementation of various dental restorations. This function relates to treatment or material modification, not to identifying a disease, condition, or health status.
No
The device description clearly states it is a "tinted, glycerine and polyethylene glycol based gel," 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 of Pulpdent OX-OUT is to block oxygen from the surface of dental restorative materials during setting. This is a direct interaction with a material being used in a dental procedure, not a test performed on a biological sample to provide diagnostic information.
- Device Description: The description confirms its function as a gel applied to the surface of dental materials.
- 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.)
- Providing diagnostic information about a patient's health condition
- Using reagents or assays to detect specific substances
The device is a material used during a dental restoration procedure to improve the setting of other materials. This falls under the category of a dental material or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting.
Pulpdent OX-OUT is indicated during cementation of metal bridges, crowns and inlays/onlays, cementation of silanated porcelain and cured composite crowns or inlays/onlays, cementation of preformed or cast posts and cores, and for bonded amalgam restorations.
Product codes
EMA
Device Description
Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting.
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)
Ultradent DeOx, Panavia Oxyguard II
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
510 k Premarket Notification
PULPDENT OX-OUT
OCT - 2 1997
EXHIBIT 7
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FAX:
TELEPHONE: (617) 926-6666
(617) 926-6262
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA.
DEVICE NAME: PREDICATE DEVICES: PULPDENT OX-OUT Ultradent DeOx Panavia Oxyguard II
DESCRIPTION AND INTENDED USE: Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting.
Pulpdent OX-OUT is indicated during cementation of metal bridges, crowns and inlays/onlays, cementation of silanated porcelain and cured composite crowns or inlays/onlays, cementation of preformed or cast posts and cores, and for bonded amalgam restorations.
COMPARISON WITH PREDICATE PRODUCTS: PPulpdent OX-OUT is substantially equivalent in composition and intended use as the products. Please see Exhibit 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: Please see Exhibit 6 for the Reality article concerning the effectiveness of these types of products. Exhibit 6 also contains the technical sheets which detail the typical safe applications and FDA status of the two major components.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 2 1997
Mr. Kenneth J. Berk Pulpdent Corporation 80 Oakland Street 02272 Watertown, Massachusetts
K972445 Re : Pulpdent Ox-Out Trade Name: Regulatory Class: II Product Code: EMA Auqust 12, 1997 Dated: Received: August 15, 1997
Dear Mr. Berk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Berk
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Millard
Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
- Enclosure
3
Page I of
510(k) Number (if known):__K97>445
Device Name: PULPDENT Ox.OuT
Indications For Use:
Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting.
Pulpdent OX-OUT is indicated during cementation of metal bridges, crowns and inlays/onlays, cementation of silanated porcelain and cured composite crowns or inlays/onlays, cementation of preformed or cast posts and cores, and for bonded amalgam restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number Prescription Use OR Over-The-Counter Use No (Per 21 CFR 801.109)
(Optional Format 1-2-96)