(74 days)
PULPDENT SEMI-GEL ETCH is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.
Pulpdent Semi-Gel Etch is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a dental etchant (Pulpdent Semi-Gel Etch), and it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Here's why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance (Table): The document states that "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." This refers to predicate devices and not specific, quantitative acceptance criteria for Pulpdent Semi-Gel Etch itself, nor does it provide performance data for this specific device against such criteria.
- Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Training Set Sample Size, Training Set Ground Truth: None of these details are present in the provided text. The submission relies on substantial equivalence to existing products rather than new clinical or performance studies with detailed methodologies.
The core of this 510(k) notification is to establish that Pulpdent Semi-Gel Etch is "substantially equivalent in design, composition and intended use" to previously approved predicate devices, not to present a new study with explicit acceptance criteria and corresponding performance data for the device.
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PU .PDENT CORPORATION
510 k Premarket Notification Pulpdent Semi-Gel Etch
EXHIBIT 2
OCT 1 1 2002
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street P J Box '80 V 'atertown, MA 02472 USA
617-926-6666 Telephone: 617-926-6262 Fax: Email: Pulpdent@pulpdent.com
| DEVICE NAME: | PULPDENT Semi-Gel Etch |
|---|---|
| PREDICATE DEVICES: | Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel |
| Pulpdent Etch-All 10 % Phosphoric Acid Etching Gel | |
| Ortho Direct Enamel Etch |
DESCRIPTION AND INTENDED USE:
Pulpdent Semi-Gel Etch is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.
COMF ARISON WITH PREDICATE PRODUCTS:
PULP DENT Semi-Gel Etch is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.
SAFE TY AND EFFECTIVENESS:
Gene al 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K022492
Trade/Device Name: Pulpdent Semi-Gel Etch Regulation Number: 872.3670 Regulation Name: Resin Impression Tray Material Regulatory Class: II Product Code: 76 EBF Dated: July 25, 2002 Received: July 29, 2002
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.
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.
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Page 2 -- Mr. Berk
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.
Patricia Cicconetti, ffe
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
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Page 1 of 1
INDICATIONS FOR USE STATEMENT
510 (k) Numbe (if known)
Device Na me
PULPDENT SEMI-GEL ETCH
Indi >ations for Use:
PULPDENT SEMI-GEL ETCH is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cem ents.
F'lease do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Frescription Use_ (i?er 21 CFR 801.109) or
Over-The-Counter Use
R.Betz DDS for Dr. S. Lunner
Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number. K022492
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.