INFILTRATION KIT

K081493 · Dmg USA, Inc. · EBC · Sep 18, 2008 · Dental

Device Facts

• Record ID: K081493
• Device Name: INFILTRATION KIT
• Applicant: Dmg USA, Inc.
• Product Code: EBC · Dental
• Decision Date: Sep 18, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sealant (Infiltrant) is indicated for: Sealing of Pit and Fissures . Sealing/facing of damaged enamel surfaces . . Covering of caries predilection sites during orthodontic treatment Sealing of secondary teeth . Sealing of deciduous teeth . The HCI Etching Gel is indicated for etching of enamel.

Device Story

Infiltration Kit consists of light-curing resin-based sealant (Infiltrant), 99.5% ethanol solution for drying/conditioning, and HCl-etching gel. Used by dental professionals in clinical settings to seal enamel pits, fissures, and damaged surfaces, or to cover caries-prone sites during orthodontics. HCl-etching gel applied first to etch enamel; ethanol solution used for conditioning; sealant applied and light-cured. Output is a sealed enamel surface. Benefits include caries prevention and protection of enamel surfaces.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Components: light-curing resin-based sealant, 99.5% ethanol solution, HCl-etching gel. Principle: enamel etching followed by resin infiltration and light-curing. Form factor: dental kit. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for sealing pits and fissures, sealing/facing damaged enamel, covering caries predilection sites during orthodontic treatment, and sealing secondary and deciduous teeth. HCI Etching Gel indicated for enamel etching.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• 3M Clinpro Sealant (K992326)
• Admira Seal (K021842)
• Grandio Seal (K062344)
• Enamel Microabrasion Compound (K891536)

Submission Summary (Full Text)

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K081493

# 510(k) Summary

| Trade Name: | Infiltration Kit |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.<br>23 Frank Mossberg Drive<br>Attleboro, MA 02703<br>Registration # not yet assigned<br>Owner/Operator No. 9005969 |
| Device Generic Name: | Infiltration Kit |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |

# Product Description:

The purposed Infiltration Kit consists of two components, a light curing resin-based sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the sealant application and as second component an HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.

# Product Indications for Use:

The Sealant (Infiltrant) is indicated for:

- Sealing of Pit and Fissures .
- Sealing/facing of damaged enamel surfaces .
- . Covering of caries predilection sites during orthodontic treatment
- Sealing of secondary teeth .
- Sealing of deciduous teeth .

The HCI Etching Gel is indicated for etching of enamel.

#### Predicate Devices:

The Infiltration Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:

| Product Name | Predicates |
|--------------------|--------------------------|
| 3M Clinpro Sealant | K992326 (3M Company USA) |
| Admira Seal | K021842 (VOCO, GmbH) |
| Grandio Seal | K062344 (VOCO, GmbH) |

#### HCI-Etching-Gel:

| Product Name | Predicates |
|-------------------------------|--------------------------------------------|
| Enamel Microabrasion Compound | K891536 (Premier Dental Products USA, Co.) |

# Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."

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K081493

# Conclusion:

・

.

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Infiltration Kit has been shown to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2008

DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device, Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K081493

Trade/Device Name: Infiltration Kit Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: September 7, 2008 Received: September 11, 2008

Dear Ms. Papineau:

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.

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Page 2 - Ms. Papineau

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 Premium results to bredicate 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Monifacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ques

Chiu S. Lin, Ph. D Division 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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K081493

Page of of

510(k) Number (if known): _ K081439

Device Name: Infiltration Kit

#### Product Indications for Use:

The Sealant (Infiltrant) is indicated for:

- Sealing of Pits and Fissures ●
- Sealing/facing of damaged enamel surfaces t
- Covering of caries predilection sites during orthodontic treatment .
- Sealing of secondary teeth .
- Sealing of deciduous teeth .

The HCI Etching Gel is indicated for etching of enamel.

Prescription Use X (Per 21 CFR 801 Subpart D) Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MSR
(Division Sign Off)

OR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091493