(66 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a dental etchant gel, with no mention of AI or ML.
No.
This device is an etchant used in tooth restoration, preparing the tooth surface for bonding. It does not treat or alleviate a disease or condition itself.
No
The device is described as an etchant used in tooth restoration. Its intended use is to prepare the tooth surface (dentin, enamel, or glass ionomers) for restoration, not to diagnose a condition.
No
The device description clearly states it is a "36% phosphoric acid etchant in gel form," which is a chemical substance, not software. The performance studies also describe bench testing of physical properties like specific gravity and solubility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for etching dental surfaces (dentin, enamel, glass ionomers) as a step in tooth restoration. This is a direct application to the patient's body (or materials being applied to the body), not for testing samples taken from the body.
- Device Description: The description details a gel applied to the tooth surface.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. The purpose is to prepare the tooth surface for bonding, a procedural step in treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pulpdent Etch-Rite Supreme is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step of tooth restoration.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in a soft gel that does not dry out quickly, that flows through small applicator tips and that washes off readily. Etch-Rite Supreme is colored dark purple for contrast with tooth enamel and easy visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth (dentin, enamel), glass ionomers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
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)
The following test results demonstrate that Etch Supreme performs as intended:
Specific gravity: 1.280
Solubility in water: 100 %
pH: 1.0
Appearance and odor: Dark purple gel with mild, characteristic odor
Shelf-Life: Two years
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
MAR 3 0 2012
・
80 Oakland Street Watertown, MA 02472 USA
TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com
510(k) Summary
January 17, 2012
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 Email: Pulpdent@pulpdent.com
| DEVICE NAME: | PULPDENT ETCH-RITE™ SUPREME |
|---|---|
| CLASSIFICATION NAME: | Resin tooth bonding agent |
| FDA PRODUCT CODE: | KLE, CFR 872.3200 |
PULPDENT C
PREDICATE DEVICES: Pulpdent Etch-Rite™ 38% Phosphoric Acid Etching Gel Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel
DESCRIPTION:
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in a soft gel that does not dry out quickly, that flows through small applicator tips and that washes off readily. Etch-Rite Supreme is colored dark purple for contrast with tooth enamel and easy visualization.
INTENDED USE
Pulpdent Etch-Rite Supreme is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent Etch-Rite Supreme is substantially equivalent in design, composition and intended use to the predicate products that have been given 510(k) Premarket approval as Class II Dental Devices under CFR 872.3200.
| | Pulpdent
Etch-Rite Supreme | Pulpdent
Etch-Rite | Pulpdent
Etch Royale |
|--------------------------|-------------------------------------------------------|--------------------------------------------------|-----------------------------------------------|
| | | K882576 | K031915 |
| Chemical
Composition: | 36% Phosphoric Acid
Silica gel
Propylene glycol | 38% Phosphoric Acid
Silica gel | 37% Phosphoric Acid
Glycerin
Silica Gel |
| Consistency | Soft gel | Thixotropic gel | Soft gel |
| Applicator tip | 25 gauge, pre-bent | 25 gauge, pre-bent | 25 gauge, pre-bent |
| Color | Dark purple | Blue | Dark blue |
| Intended Use | Etch dentin, enamel and
glass ionomer cements | Etch dentin, enamel and
glass ionomer cements | Etch dentin and tooth
enamel. |
1
PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com
510(k) Summary
Summary of Performance Testing - Bench
The following test results demonstrate that Etch Supreme performs as intended:
| Specific gravity | 1.280 |
|---|---|
| Solubility in water | 100 % |
| pH | 1.0 |
| Appearance and odor | Dark purple gel with mild, characteristic odor |
| Shelf-Life | Two years |
CONCLUSION:
From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with the Etch-Rite line of etchants, it can be concluded that Etch-Rite Supreme is substantially equivalent in design, composition, performance and intended use to the predicate products. General usage of Etch-Rite for more than 20 years and Etch Royale for over 10 indicates a high benefit-to-risk ratio.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street Watertown, MA 02472
MAR 3 0 2012
Re: K120213
Trade/Device Name: Pulpdent Etch-Rite™ Supreme Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: January 17, 2012 Received: January 24, 2012
Dear Mr. Berk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Mr. Berk:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
4
Indications for Use
20213
510(k) Number (if known):
Device Name: Pulpdent Etch-Rite ™ Supreme
Indications For Use:
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.
Prescription Use X (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)
Susan Rumm
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K062613
Page 1 of 1