SPLASH! IMPRESSION MATERIAL DEVICE

K052090 · Discus Dental, Inc. · ELW · Aug 5, 2005 · Dental

Device Facts

• Record ID: K052090
• Device Name: SPLASH! IMPRESSION MATERIAL DEVICE
• Applicant: Discus Dental, Inc.
• Product Code: ELW · Dental
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

Device Story

Splash!® Dental Impression Material is an addition-reaction polyvinylsiloxane (PVS) material used by dental professionals to create accurate dental impressions. The material is supplied as a base/catalyst system in heavy viscosity, available in regular or fast-setting (Half-time) varieties. It is applied by clinicians during crown, bridge, occlusal, and dental implant procedures to capture the anatomical structure of teeth and gums. The material sets in the patient's mouth to form a physical mold, which is then used to fabricate dental restorations or appliances. It provides high dimensional stability and recovery from deformation, aiding in the precision of dental restorative workflows.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing comparing physical properties (ISO 4823 classification, recovery from deformation, shrinkage, hardness, and strain in compression) against predicate devices.

Technological Characteristics

Addition-reaction polyvinylsiloxane (PVS) dental impression material. Available in heavy viscosity. Meets ISO 4823 Type 0-3 standards. Physical properties: 99.2-99.5% recovery from deformation, <0.10% shrinkage, 62-67 Shore A hardness. Storage conditions: 15-25°C.

Indications for Use

Indicated for use in dental patients requiring impressions for crowns, bridges, occlusal, and dental implant procedures to reproduce tooth and gum structures.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Precision VPS Impression Material (K040053)
• P2 Polyether (K030318)
• Aquasil Smart Wetting (K021416)

Submission Summary (Full Text)

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K052090

AUG 5 - 2005

#### Summary of Safety and Effectiveness II.

Date of Summary:

### Splash!® Dental Impression Material

- 2. Date of Summary July 15, 2005 Preparation: Discus Dental, Inc. 3. Submitting Firm: 4. Contact Person Suzanne Ridgway Regulatory Affairs Coordinator Discus Dental, Inc. 8550 Higuera Street Culver City, CA 90232 310.845-8345 - phone [phone] - fax 5. Name of Medical Device Proprietary Name: Splash!® Dental Impression Material Common/Usual Name: Dental Impression Material
- Classification Name: Impression Material
- 6. Description of Medical Device

Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.

- 7. Intended Use
1.

Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

- 8. Substantial Equivalence Determination
Evaluations and in-house testing of the new Splash!® Dental Impression Material device by Discus Dental, Inc. have shown this device to be substantially equivalent to the following commercially marketed impression materials:

002

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| Predicate Device<br>(Primary) | Company | 510(k) No. |
|--------------------------------------|--------------------|------------|
| Precision VPS Impression<br>Material | Discus Dental | K040053 |
| Predicate Device<br>(Secondary) | Company | 510(k) No. |
| P2 Polyether | Heraeus Kulzer Inc | K030318 |
| Aquasil Smart Wetting | Denstply, Intl. | K021416 |

## Predicate Similarities

| Product | Company | ISO 4823 | Recovery from<br>Deformation | Shrinkage | Storage<br>Conditions |
|--------------|-------------------|----------|------------------------------|-----------------|----------------------------|
| Splash! | Discus<br>Dental | Type 0-3 | 99.2- 99.5% | Max.<br><0.10% | 59° -78° F<br>(15° -25° C) |
| Aquasil | Dentsply | Type 1-3 | >98.0% | <0.50% | 65° -80° F<br>(18° -25° C) |
| P2 Polyether | Heraeus<br>Kulzer | Type 1-3 | 97.5 - 98.0% | 0.40 -<br>0.50% | 65° -80° F<br>(18° -25° C) |
| Precision | Discus<br>Dental | Type 0-3 | 99.3- 99.6% | Max.<br><0.10% | 59° -78° F<br>(15° -25° C) |

# Predicate Differences

| Product | Company | Working time | Hardness (Shore A) | Strain in Compression | Shrinkage | Storage Conditions |
|--------------|----------------|------------------|--------------------|-----------------------|--------------------------|--------------------------------------|
| Splash! | Discus Dental | 55 sec - 65 sec | 62- 67 | 2.3 - 2.5% | Max.<0.10% | 59 o -78o F (15o -25o C) |
| Aquasil | Dentsply | 75 sec - 105 sec | Data Not Available | 1 - 5% | <0.50% | 65o -80o F (18o -25o C) |
| P2 Polyether | Heraeus Kulzer | 120 sec. | 44 - 64 | 4.3 - 10% | 0.40 - 0.50% | 65o -80o F (18o -25o C) |
| Precision | Discus Dental | 45 - 105 sec | 44 - 69 | 2.1 - 4.5% | 0.10% | 59o -78o F (15o -25o C) |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

Discus Dental, Incorporated C/O Dr. Alfredo J. Quattrone Responsible Third Party Official California Department of Health Services Food & Drug Branch P.O. Box 997 413 Sacramento, California 95899-74413

Re: K052090

Trade/Device Name: Splash! Impression Material Device Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 26, 2005 Received: August 2, 2005

Dear Dr. Quattrone:

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 - Dr. Quattrone

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sufitte y. Michan Oms

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

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### V. Indications for Use Statement

510(k) Number:

Device Name: Splash! Impression Material

... .

"

Intended Use

Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR Section 801.109)

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Over-The-Counter Use __

Sper Suaser

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

510(k) Number: K052040

Discus Dental, Inc.