(190 days)
No
The device description and performance studies focus on the chemical and physical properties of an etching gel, with no mention of AI or ML.
No
The device is an etching gel used in tooth restoration procedures, which is a preparatory step rather than a direct treatment for a disease, injury, or to restore or modify body functions.
No
Explanation: The device is an etching gel used for surface preparation before tooth restoration, which is a treatment-related function, not a diagnostic one. It doesn't identify or characterize a disease or condition.
No
The device description clearly states it is a "38% phosphoric acid etching gel in a soft gel form," 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 is to "etch the dentin and enamel before tooth restoration treatments." This is a direct treatment or preparation for a treatment performed on the patient's body (in vivo).
- Device Description: The description confirms it's a gel applied to the tooth structure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used to analyze samples like blood, urine, tissue, etc., to provide diagnostic information. This device is used directly on the patient's teeth for a preparatory step in a dental procedure.
N/A
Intended Use / Indications for Use
EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.
Product codes
KLE
Device Description
EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin and enamel of teeth.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
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)
Non-Clinical performance Data: The side-by-side performance tests with EtchPro® Etching Gel and Acid Etch-Rite) were conducted. The following items were tested: phosphoric acid concentration, pH, and viscosity. The biocompatibility tests were performed and the data showed that EtchPro® Etching Gel is substantial equivalent to Acid Etch Gel (Etch-Rite).
Clinical performance Data: Clinical data was not included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 2, 2020
Daisy Ni, Regulatory Affairs Manager Belport Company, Inc., Gingi-Pak 4825 Calle Alto. Camarillo, California 93012
Re: K200462
Trade/Device Name: EtchPro Etching Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: June 1, 2020 Received: June 5, 2020
Dear Daisy Ni:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number : K200462
Device Name: EtchPro® Etching Gel
Indications for Use:
EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.
Type of Use:
Prescription Use ___________ OR Over-The-Counter Use
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K200462 510(k) Summary
Date Prepared:
September 1, 2020
Applicant:
Belport Company, Inc., Gingi-Pak
Address: 4825 Calle Alto, Camarillo, CA 93012
Telephone: (805) 484-1051
Correspondent Contact:
Daisy Ni, Regulatory Affairs Specialist
- Telephone: (805) 484-1051 .
- Email: dnpacdent@gmail.com
Jiahe Li, Regulatory Affairs Specialist
- . Telephone: (805) 484-1051
Device Information:
DEVICE NAME: EtchPro® Etching Gel
TRADE NAME: EtchPro® Etching Gel
COMMON NAME: Tooth etching gel
DEVICE CLASSIFICATION Name: Resin, Tooth Bonding Agent
CLASSIFICATION REGULATION NUMBER: CFR 872.3200 DEVICE CLASSIFICATION: CLASS II CLASSIFICATION PRODUCT CODE: KLE
Predicate Device
| Product Name | Registration No. | Manufacturer | |
|---|---|---|---|
| Predicate | |||
| Device | Etch-Rite Royale | K031915 | Pulpdent Corporation |
| Reference | |||
| Device | Acid Etch Gel | K882576 | Pulpdent Corporation |
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Description of Device
EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.
Indications for Use
EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.
Substantial equivalence
A side-by-side comparison table is provided. The similarities among the subject, predicate and reference devices are discussed below.
| Item
Name | Subject device | Predicate
Device | Reference Device | Substantial
equivalence
Analysis |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Device
name | EtchPro®
Etching Gel | Etch- Rite
Royale | Acid Etch Gel
(Etch-Rite) | - |
| Manu-
facturer | Belport
Company, Inc.,
Gingi-Pak | Pulpdent
Corporation | Pulpdent
Corporation | |
| 510(K)
No. | K200462 | K031915 | K882576 | |
| Classifi-
cation
Name | Resin, Tooth
Bonding Agent | Resin, Tooth
Bonding Agent | Tooth shade resin
material. | Same as the
predicate device |
| Regula-
tory
Class | Class II | Class II | Class II | Same |
| Product
Code | KLE | KLE | EBF | Same as the
predicate device |
| Intended
Use | Etch the dentin
or enamel | Etching
dentin
or enamel | Etch the dentin,
enamel and glass
ionomer cements | Same as the
predicate device |
| Descrip-
tion of
Device | EtchPro®
Etching Gel is a
38% phosphoric
acid etching gel
in a soft gel
form that is
used by dental
professionals
for etching
dentin and | 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 | Etch-Rite Etching
Gel is a 38%
phosphoric acid
etching gel in a
thixotropic gel form
that is used by the
dental professional
for etching dentin
or enamel before
tooth restoration. | Same as the
reference device
for active
ingredient and
concentration.
Same as the
predicate for the
soft gel form. |
| | enamel before
tooth
restoration. | 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 | | All devices are for
dental
professional use. |
| Ingredient | 38%
phosphoric acid
Silica
Glycerin
Colorant | 37%
phosphoric acid
Silica
Glycerin
Colorant | 38%
phosphoric acid
Silica
Colorant | Same ingredients
Same as the
reference device
for the
concentration of
active ingredient
(38% phosphoric
acid). |
| Consistency | Soft gel | Soft gel | Thixotropic gel | Same as the
predicate device |
| Color | Dark blue | Dark blue | Medium blue | Same as the
predicate device |
| Solubility
in water | 100% | 100% | 100% | Same |
| Design/
Packaging | Pre-filled
syringes with
applicators, in
1.2 ml and 30
ml | Pre-filled
syringes with
applicators, in
1.2 ml, 6ml and
25 ml | Pre-filled syringes
with applicators, in
1.2 ml and 25 ml | Same
packing/design
except volume
differences. |
| OTC or
Rx | Rx | Rx | Rx | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf Life | 2 years | 2 years | 2 years | Same |
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The intended use of the EtchPro® Etching Gel is same to that of the predicate device Pulpdent Etch-Rite Etching Gel as they are both indicated to Etch dentin and enamel. EtchPro® Etching, predicate device and reference device share the same ingredients, except EtchPro® Etching
6
Gel includes glycerin while Acid Etch Gel (Etch-Rite) does not. Glycerin is a humectant, a FDA recognized generally recognized as safe (GRAS) inactive ingredient.
Non-Clinical performance Data
The side-by-side performance tests with EtchPro® Etching Gel and Acid Etch-Rite) were conducted. The following items were tested: phosphoric acid concentration, pH, and viscosity. The biocompatibility tests were performed and the data showed that EtchPro® Etching Gel is substantial equivalent to Acid Etch Gel (Etch-Rite).
Clinical performance Data
Clinical data was not included in this submission.
Conclusion
Based on the similarities in indications for use and technological characteristics together with results of non-clinical performance testing, we believe that EtchPro® Etching Gel is substantially equivalent to the predicate devices.