← Product Code OLR · K053342

# GENGIGEL MOUTHRINSE (K053342)

_Ricerfarma Srl · OLR · Mar 13, 2007 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K053342

## Device Facts

- **Applicant:** Ricerfarma Srl
- **Product Code:** OLR
- **Decision Date:** Mar 13, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort. Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort. Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

## Device Story

Gengigel line (Gel, Prof Gel, Fluid, Junior, Spray, Mouthrinse) consists of hydrogel-based oral dressings; applied to oral mucosa to form protective film over lesions/irritations; acts as physical barrier against ongoing insult; provides temporary pain relief. Used in clinical or home settings; applied by clinician or patient. No complex electronics or software; purely mechanical barrier function.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Hydrogel-based oral dressing; non-sterile; physical barrier principle; various form factors (gel, fluid, spray, mouthrinse).

## Regulatory 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

- Gelclair® Oral Gel ([K013056](/device/K013056.md))
- Aloclair™ Oral Gel ([K040950](/device/K040950.md))
- Aloclair™ Oral Spray ([K042722](/device/K042722.md))
- Aloclair™ Oral Rinse ([K023155](/device/K023155.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

Gengigel® Prof Gel Premarket Notification K053342 February 15, 2007

#### Summary of Safety and Effectiveness 3

MAR 1 3 2007

Date Summary Prepared:

February 15, 2007

Applicants Name:

Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy

Contact Person:

Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net

Device Name: Classification Name:

- Product Code: CFR Section: Device Class: Classification Panel:
Indications:

Gengigel® Prof Gel. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery

Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

### Predicate Device

| K013056                       |
|-------------------------------|
| Gelclair® Oral Gel            |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK          |
| Product Code-MGQ              |

{1}------------------------------------------------

Gengigel® Prof Fluid Premarket Notification K053342 February 15, 2007

### Summary of Safety and Effectiveness 3

Date Summary Prepared:

February 15, 2007

Applicants Name:

Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy

Contact Person:

Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net

Device Name: Classification Name:

- Product Code: CFR Section: Device Class: Classification Panel:
Gengigel® Prof Fluid. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery

Indications: Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

### Predicate Devices

| K013056                       |
|-------------------------------|
| Gelclair® Oral Gel            |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK          |
| Product Code-MGQ              |

{2}------------------------------------------------

K053342

Gengigel® Junior Premarket Notification K053342 February 15, 2007

#### Summary of Safety and Effectiveness 3

| Date Summary Prepared: | February 15, 2007                                |
|------------------------|--------------------------------------------------|
| Applicants Name:       | Ricerfarma Srl                                   |
|                        | Via Egadi, 7-20144                               |
|                        | Milano, Italy                                    |
| Contact Person:        | Paul Ketteridge, (Consultant to Ricerfarma)      |
|                        | 303 Patleigh Road                                |
|                        | Catonsville, MD 21228                            |
|                        | 443 729-0836                                     |
|                        | p.kett@comcast.net                               |
| Device Name:           | Gengigel® Junior.                                |
| Classification Name:   | Dressing, Wound and Burn, Hydrogel w/Drug and/or |
|                        | Biologic                                         |
| Product Code:          | MGQ                                              |
| CFR Section:           | None                                             |
| Device Class:          | Unclassified                                     |
| Classification Panel:  | General and Plastic Surgery                      |

Indications: Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

: 1

### Predicate Device

i .

| K040950                       |  |
|-------------------------------|--|
| Aloclair™ Oral Gel            |  |
| Sinclair Pharmaceuticals, Ltd |  |
| Godalming, Surrey,UK          |  |
| Product Code-MGQ              |  |

{3}------------------------------------------------

K053342

Gengigel® Spray Premarket Notification K053342 February 15, 2007

### Summary of Safety and Effectiveness 3

| Date Summary Prepared: | February 15, 2007                                                                                                               |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Applicants Name:       | Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy                                                                           |
| Contact Person:        | Paul Ketteridge, (Consultant to Ricerfarma)<br>303 Patleigh Road<br>Catonsville, MD 21228<br>443 729-0836<br>p.kett@comcast.net |
| Device Name:           | Gengigel® Spray.                                                                                                                |
| Classification Name:   | Dressing, Wound and Burn, Hydrogel w/Drug and/or<br>Biologic                                                                    |
| Product Code:          | MGQ                                                                                                                             |
| CFR Section:           | None                                                                                                                            |
| Device Class:          | Unclassified                                                                                                                    |
| Classification Panel:  | General and Plastic Surgery                                                                                                     |

Indications: Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Predicate Device:

.

: 上一篇: 上一篇:

. .

| K042722                       |
|-------------------------------|
| Aloclair™ Oral Spray          |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK          |
| Product Code-MGQ              |

{4}------------------------------------------------

K053342

Gengigel® Gel Premarket Notification K053342 February 15, 2007

#### Summary of Safety and Effectiveness 3

February 15, 2007 Date Summary Prepared:

Applicants Name:

Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy

Contact Person:

Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net

Device Name: Classification Name:

- Product Code: CFR Section: Device Class: Classification Panel:
Gengigel® Gel. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery

Indications: Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

### Predicate Devices

| K040950                       |
|-------------------------------|
| Aloclair™ Oral Gel            |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK          |
| Product Code-MGQ              |

{5}------------------------------------------------

# K053342

Gengigel® Mouthrinse Premarket Notification K053342 February 15, 2007

### Summary of Safety and Effectiveness 3

| Date Summary Prepared: | February 15, 2007                                                                                                               |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Applicants Name:       | Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy                                                                           |
| Contact Person:        | Paul Ketteridge, (Consultant to Ricerfarma)<br>303 Patleigh Road<br>Catonsville, MD 21228<br>443 729-0836<br>p.kett@comcast.net |
| Device Name:           | Gengigel® Mouthrinse.                                                                                                           |
| Classification Name:   | Dressing, Wound and Burn, Hydrogel w/Drug and/or<br>Biologic                                                                    |
| Product Code:          | MGQ                                                                                                                             |
| CFR Section:           | None                                                                                                                            |
| Device Class:          | Unclassified                                                                                                                    |
| Classification Panel:  | General and Plastic Surgery                                                                                                     |

Indications: Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. 

### Predicate Device

.

| K023155                       |
|-------------------------------|
| Aloclair™ Oral Rinse          |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey, UK         |
| Product Code-MGQ              |

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ricerfarma SRL C/O Mr. Paul Ketteridge Consultant PD Regulatory Consulting, LLC 303 Patleigh Road Catonsville, Maryland 21228

MAR 1 3 2007

Re: K053342

Trade/Device Name: Gengigel® Mouthrinse Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: February 15, 2007 Received: February 16, 2007

Dear Mr. Ketteridge:

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.

{7}------------------------------------------------

Page 2 -Mr. Ketteridge

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 (240) 276-0115. 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 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

K053342

Gengigel® Junior Premarket Notification K053342 February 15, 2007

### Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Junior

Indications for Use:

- Gengigel® Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use XXX (21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _ of (Posted November 13, 2003)

Susan Bunner

KC53342

{9}------------------------------------------------

K053342

Gengigel® Prof Fluid Premarket Notification K053342 February 15, 2007

#### Indications for Use 1

510(k) Number (if known): K053342

Device Name: _Gengigel® Prof Fluid

Indications for Use:

Gengigel® Prof Fluid adheres to the oral mucosa and forms a Gengigel® protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)

Susan Runor

KCS3342

{10}------------------------------------------------

Gengigel® Spray Premarket Notification K053342 February 15, 2007

K053342

#### Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Spray

Indications for Use:

Gengigel Spray provides temporary pain relief by adhering to the Gengigel® oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use __ XX AND/OR (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)

Susan Rumpes

{11}------------------------------------------------

K05334.2

Gengigel® Prof Gel Premarket Notification K053342 February 15, 2007

#### 1 Indications for Use

510(k) Number (if known):

Device Name: _Gengigel® Prof Gel

Indications for Use:

Gengigel® Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of (Posted November 13, 2003)

Susan Runne

KC53342

{12}------------------------------------------------

K053342

Gengigel® Gel Premarket Notification K053342 February 15, 2007

#### Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Gel

Indications for Use:

Gengigel®

Gengigel Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XX (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of (Posted November 13, 2003)

Susan Runore

K053342

{13}------------------------------------------------

Gengigel® Mouthrinse Premarket Notification K053342 February 15, 2007

#### Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Mouthrinse

Indications for Use:

Gengigel Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use XX (21 CFR 801 Subpart C)

K053342

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)

Susan Pamon

transportation

justification

---

**Source:** [https://fda.innolitics.com/device/K053342](https://fda.innolitics.com/device/K053342)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com