Who is the manufacturer of Silatrix Oral Gel?

Sa3, LLC filed the 510(k) submission for Silatrix Oral Gel (K202000).

What is the FDA product code for Silatrix Oral Gel?

OLR. as a Class U device in the SU panel.

What is the regulatory pathway for Silatrix Oral Gel?

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

What are the predicate devices for Silatrix Oral Gel?

ProThelial & Orafate Sucralfate Paste (K123904).

Who can help prepare an FDA 510(k) submission like Silatrix Oral 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.

Silatrix Oral Gel

K202000 · Sa3, LLC · OLR · Nov 20, 2020 · SU

Device Facts

Record ID	K202000
Device Name	Silatrix Oral Gel
Applicant	Sa3, LLC
Product Code	OLR · SU
Decision Date	Nov 20, 2020
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic, Pediatric

Intended Use

Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.

Device Story

Silatrix Oral Gel is an amorphous hydrogel composed of sucralfate, malic acid, calcium carbonate, and other excipients. It is applied topically to oral mucosal wounds by the patient or clinician. The device functions via physical action; it binds reversibly to the wound bed to form an adherent protective film. This barrier protects the wound from further irritation and provides pain relief. The gel self-buffers to a pH of 5.0–7.0. It is supplied non-sterile in a tube for prescription use. By creating a physical covering, it aids in the management of various oral lesions and ulcers, potentially improving patient comfort and facilitating the natural healing process.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance data, including USP standard verification of the sucralfate component and biocompatibility testing (cytotoxicity, sensitization, and irritation).

Technological Characteristics

Amorphous hydrogel; ingredients include sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water. Self-buffering to pH 5.0-7.0. Non-sterile, semisolid topical application. No electronic or software components.

Indications for Use

Indicated for pediatric and adult patients for the management of mouth lesions, including aphthous ulcers, stomatitis, mucositis, minor lesions, chafing, traumatic ulcers, abrasions from braces or dentures, and lesions associated with oral surgery.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

ProThelial & Orafate Sucralfate Paste (K123904)

Reference Devices

Synvaza and Synvaza II (K193336)

Related Devices

K252425 — Silatrix Oral Gel · Sa3, LLC · Oct 23, 2025
K123904 — PROTHELIAL · Mueller Medical International, LLC · Aug 7, 2013
K043587 — SUCRALFATE AND CARAFATE PASTE KITS · Patrick D. Mcgrath Ph.D · Feb 3, 2006
K082856 — CARAPASTE ORAL WOUND DRESSING · Mcgrath Pharmaceuticals, Inc. · Oct 15, 2008
K191987 — Orapeutic · Forward Science · Nov 27, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. November 20, 2020 Sa3. LLC % Daniel Schultz Principal, Devices and Combination Products Greenleaf Health, Inc. 1055 Thomas Jefferson Street, NW, Suite 450 Washington, District of Columbia 20007 Re: K202000 Trade/Device Name: Silatrix Oral Gel Regulatory Class: Unclassified Product Code: OLR, FRO Dated: August 31, 2020 Received: September 1, 2020 Dear Dr. Daniel Schultz: 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. {1}------------------------------------------------ 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 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Statement of Indications for Use (FDA Form 3881) ## Indications for Use 510(k) Number (if known): K202000 Device Name: Silatrix Oral Gel Indications for Use: Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for SA3, LLC. The logo consists of a green asterisk-like symbol on the left, followed by the text "SA3, LLC" in a teal color. The asterisk symbol has a circle in the center and eight lines radiating outwards. 2317 Cotner Avenue Los Angeles, CA 90064-1803 888.495.6078 888.502.1669 info@SA3pharma.com ## 510(k) SUMMARY K202000 ## Silatrix Oral Gel ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared SA3, LLC 2317 Cotner Avenue Los Angeles, CA 90064 Phone: 310.282.8086 Fax: 888.502.1669 Contact Person: Farbod Melamed, Pharmacist Date Prepared: 11/20/20 #### Name of Device and Name/Address of Sponsor Silatrix Oral Gel SA3. LLC 2317 Cotner Avenue Los Angeles, CA 90064 ## Common or Usual Name Polymerized cross-linked sucralfate gel treatment #### Classification Name Product Code: OLR, FRO Unclassified Oral Wound Dressing, Dressing, Wound, Drug ## Primary Predicate K-Number: K123904 Common or Usual Name: Sucralfate Malate Paste Trade/Proprietary/Model Name: ProThelial & Orafate Sucralfate Paste Classification Name: Dressing, Wound, Drug Product Code: FRO Classification: Unclassified Applicant: Mueller Medical International LLC {4}------------------------------------------------ ## Reference Device K-Number: K193336 Common or Usual Name: Synvaza and Synvaza II Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Product Code: MGQ Classification: Unclassified Applicant: Synedgen, Inc. # Device Description The proposed Silatrix Oral Gel is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. The intended use of this device is achieved by physical action. Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by the reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7 .0, the subject device achieves its primary mode of action through serving as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. There is no chemical action or metabolic effect associated with the mechanism of action of this device. Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a small tube. ## Indications for Use Silatrix Oral Gel forms a protective laver over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. ## Nonclinical Performance Data Non-clinical performance data relied on in this determination of substantial equivalence demonstrate the identical nature of the clinically effective component of the Silatrix Oral Gel and its predicate device, the ProThelial & Orafate Sucralfate Paste. The clinically effective component is sucralfate USP, without which neither device would function. The non-clinical tests involved those required by USP national standards to verify the presence of sucralfate. The sucralfate used in each of the devices is an o-D-glucopyranoside, P- Dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex, molecular weight of 2,086.75. {5}------------------------------------------------ Biocompatibility testing was conducted for the proposed device. As the proposed device is an amorphous hydrogel for topical use in oral mucosa, all components of the device are considered direct contact components. Cytotoxicity, Sensitization and Irritation testing was conducted. The results showed that the Silatrix Oral Gel is not considered to be cytotoxic and not considered to be a contact skin sensitizer or an oral irritant. Shelf life testing was also conducted for the proposed device. ## Substantial Equivalence The proposed Silatrix Oral Gel has the same intended use as its primary predicate device, namely to serve as a physical barrier on oral mucosal tissues, to protect against further irritation and manage or relieve pain. In addition, the proposed Silatrix Oral Gel features identical indications for use language, similar technological characteristics and principles of operation. The minor technological difference between these two devices is in the dosage form and excipients. The proposed device, the Silatrix Oral Gel and its primary predicate, the ProThelial & Orafate Sucralfate Paste are described as a gel and paste respectively, which are still viscous aqueous gel formulations. Both devices are semisolid for topical application and are free of fatty vehicles. As per FDA's definitions of gel and paste, the dosage form gel describes the Silatrix Oral Gel better than the paste. The differences in the technological characteristics between closely related paste and gel dosage forms for topical application do not raise new questions of safety or effectiveness. However, to further support the substantial equivalence of the proposed device, a reference device was introduced to capture the hydrogel technology featured in the proposed device. Reference device Synvaza (and Synvaza II) is also an oral wound dressing available in a hydrogel formulation, just as found in the proposed Silatrix Oral Gel. | Substantial Equivalence Chart | | | | | | | Ingredients | Sucralfate, malic acid, calcium carbonate, xanthan gum, calcium sulfate dihydrate, purified water, sucralose, propylene glycol | Sucralfate, malic acid, calcium carbonate, xanthan gum, calcium sulfate, purified water, methyl parabens, propyl parabens, sodium saccharin | Water, sorbitol, glycerin, betaine, (benzoic acid- Synvaza II) chitosan derivatives, sodium hydroxide | |-------------------------------|-----------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Device Number | K202000 | K123904 | K193336 | No. Application per Day | Apply to mucosal wounds 2 to 3 times daily. | Application to mucosal wounds 2 -3 times daily. | Swish 1-3 teaspoons of rinse in mouth for 1 minute and spit out; use up to 10 times daily. | | | | | Product Name | Silatrix Oral Gel (Proposed Device) | ProThelial & Orafate Sucralfate Paste | Synvaza and Synvaza II | Claim | Management and relief of pain, does not sting, nonirritating, safe if swallowed. | Management and relief of pain, non- irritating, safe if swallowed. | Management of pain and maintenance of a moist wound environment. | | | | | Applicant | SA3, LLC | Mueller Medical International LLC | Synedgen, Inc. | Mechanism of Action | Amorphous hydrogel binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. | Device binds reversibly to wounds to form a protective film where local wound bed acidity is not available or present on oral mucosa. Provides an adherent physical covering of the wound bed. | Polysaccharide polymer from a natural source that adheres to oral mucosa and protects it from irritation by forming a protective barrier. It also creates a moist wound environment, which is necessary for the natural healing process. | | | | | Classification Name | Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic | Dressing, Wound, Drug | Dressing, Wound and Burn Hydrogel W/ Drug and/or Biologic | Intended Use | Form a protective film that covers oral wounds, protects against further irritation and relieves pain | Form a protective film over oral mucosal wounds; relieves pain. | Management of pain and maintenance of a moist wound environment. | | | | | Classification | Unclassified | Unclassified | Unclassified | Indication | Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery | ProThelialTM & Orafate Sucralfate Malate Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. | Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers; aphthous ulcers. | | | | | Product Code | OLR, FRO | FRO | OLR, FRO | Description | Silatrix Oral Gel is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers | ProThelial & Orafate Sucralfate Paste is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to | Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation | | | | | Type | Rx Medical device | Rx Medical Device | OTC Medical Device | | | | | | | | | Patient Group | Pediatric & Adult | Pediatric & Adult | Pediatric & Adult | | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | | wounds, protects against further irritation and relieves pain. Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7.0. | form a protective film that covers wounds, protects against further irritation and relieves pain. ProThelial"" & Orafate Sucralfate Paste may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with an acid, the polymerized sucralfate self- buffers to a pH 5.0 - 7.0. | results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Area of Use | Oral Mucosa | Oral Mucosa | Oral Mucosa | | Type of Product | Gel | Paste | Gel | | Presentation | Non-Sterile | Non-Sterile | Non-Sterile | # Conclusions: The Silatrix Oral Gel and the predicate device, the ProThelial & Orafate Sucralfate Paste, have the same intended use and similar indications, technological characteristics and principles of operation. The only technological difference between the Silatrix Oral Gel and its predicate is the difference in dosage form and excipients. As explained above, these differences do not present any new issues of safety or effectiveness. The performance data also demonstrates the identical nature of the sucralfate component in these two devices. Thus, the Silatrix Oral Gel is substantially equivalent to the ProThelial & Orafate Sucralfate Paste.