Who is the manufacturer of EtchPro Etching Gel?

Belport Company, Inc., Gingi-Pak filed the 510(k) submission for EtchPro Etching Gel (K200462).

What is the FDA product code for EtchPro Etching Gel?

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

What is the regulatory pathway for EtchPro Etching Gel?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EtchPro Etching Gel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EtchPro Etching Gel

K200462 · Belport Company, Inc., Gingi-Pak · KLE · Sep 2, 2020 · Dental

Device Facts

Record ID	K200462
Device Name	EtchPro Etching Gel
Applicant	Belport Company, Inc., Gingi-Pak
Product Code	KLE · Dental
Decision Date	Sep 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

Intended Use

EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.

Device Story

EtchPro® Etching Gel is a 38% phosphoric acid gel used by dental professionals in clinical settings. It is applied to dentin and enamel to prepare tooth surfaces for restoration. The gel contains phosphoric acid, silica, glycerin, and colorant. It is supplied in pre-filled syringes with applicators. The clinician applies the gel to the target area; the acidic properties etch the tooth structure to facilitate bonding. The gel is water-soluble and rinses away completely. The dark blue color provides contrast for visualization during application. The device is non-sterile and intended for prescription use.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing comparing phosphoric acid concentration, pH, viscosity, and biocompatibility against the predicate device.

Technological Characteristics

38% phosphoric acid gel; contains silica, glycerin, and colorant. Non-sterile. Supplied in pre-filled syringes (1.2 ml and 30 ml). Water-soluble (100%). Shelf life: 2 years. No software or electronic components.

Indications for Use

Indicated for dental professionals to etch dentin and enamel prior to tooth restoration treatments.

Regulatory Classification

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.

Predicate Devices

Etch-Rite Royale (K031915)

Reference Devices

Acid Etch Gel (K882576)

Related Devices

K152110 — e-1 etchants · E Dental Products · Nov 20, 2015
K131248 — ETCH GEL · Dmg America, LLC · Jul 11, 2013
K031915 — PULPDENT ETCH-RITE ROYALE · Pulpdent Corporation · Aug 5, 2003
K990306 — HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 · Kay See Dental Mfg. Co. · Mar 3, 1999
K112597 — SEITY 37% PHOSPHORIC ACID ETCHANT GEL · Mycone Dental Supply Co., Inc. · Dec 7, 2011

Submission Summary (Full Text)

{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 {2}------------------------------------------------ # 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 {3}------------------------------------------------ # 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 | {4}------------------------------------------------ # 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 | {5}------------------------------------------------ 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.