(46 days)
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Not Found
No
The device description and intended use clearly describe a chemical etchant gel, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is an etchant used to prepare teeth for restoration, not to treat a disease or condition. Its purpose is preparatory, not therapeutic.
No
The device is described as an etchant used for etching dentin or enamel before tooth restoration, which is a preparatory step for treatment, not a diagnostic one.
No
The device description clearly states it is a "37% phosphoric acid etchant in gel form," indicating it is a chemical 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 is for etching dentin or enamel before tooth restoration. This is a procedure performed directly on the patient's tooth for a therapeutic or restorative purpose.
- Device Description: The description reinforces its use as a topical application on the tooth surface.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from a patient. This device is used in vivo (on the body) as part of a dental procedure.
N/A
Intended Use / Indications for Use
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin or enamel (tooth surfaces)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional
Description of the training set, sample size, data source, and annotation protocol
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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): 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.
Pulpdent Semi-Gel Etchant 35% Phosphoric acid Etchant, Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel
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.
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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).
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§ 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
AUG - 5 2003
510 k Premarket Notification Pulpdent Etch-Rite Royale
EXHIBIT 2
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 617-926-6262 Fax: Email: Pulpdent@pulpdent.com
| DEVICE NAME: | PULPDENT ETCH-RITE ROYALE |
|---|---|
| PREDICATE DEVICES: | Pulpdent Semi-Gel Etchant 35% Phosphoric acid Etchant |
| Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel |
DESCRIPTION AND INTENDED USE:
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent Etch-Rite Royale is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS:
General usage of the predicate products over more than 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class II Dental Devices under CFR 872.3690. Please see Exhibit 4 for 510(k) numbers.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.
Public Health Service
AUG - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K031915
Trade/Device Name: Pulpdent Etch-Rite Rovale Regulation Number: 21 CFR 872.3200 Regulation Name: Resin, Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 13, 2003 Received: June 24, 2003
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.
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.
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Page 2 - Mr. Kenneth J. 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); 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.
Susan Runnr
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
11-031915
510 (k) Number (if known)
Device Name Pulpdent Etch-Rite Royale
Indications for Use:
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert S. Betz DDS for Dr. K. Mulry
(Division Sign-Off) Division of Anesthesiology, General Hospi Infection Control, Dental De
510(k) Number: K031915
or
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use