PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT

K082560 · Kettenbach GmbH & Co. KG · ELW · Sep 8, 2008 · Dental

Device Facts

• Record ID: K082560
• Device Name: PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
• Applicant: Kettenbach GmbH & Co. KG
• Product Code: ELW · Dental
• Decision Date: Sep 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Panasil® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.

Device Story

Panasil® Impression Materials are addition-curing, elastomeric dental materials; available in five viscosities (putty, heavy, medium, light, x-light). Used by dental professionals in clinical settings to capture precise anatomical structures of teeth and gums. Materials are applied via impression trays or direct intraoral injection using automix cartridges or automatic dispensing systems. The material cures to form a stable, dimensionally accurate negative replica of the oral cavity. This replica is used to create physical models for study or as a foundation for fabricating prosthetic restorations (crowns, bridges, dentures, implants). Benefits include high tear strength and resistance to deformation, ensuring accurate fit of final dental prosthetics.

Clinical Evidence

Bench testing only. Evaluated per FDA Guidance for Industry: Dental Impression Materials and ISO 4823:2000/Cor 1:2004/Amd 1:2007. Testing confirmed suitability for use as dental impression materials and performance equivalent to predicate devices.

Technological Characteristics

Addition-curing elastomeric impression materials. Hydrophilic properties, high tear strength, dimensional accuracy. Available in five viscosities. Delivery systems: 1:1 50 ml automix cartridges, 5:1 362 ml foil bags, and putty jars. Complies with ISO 4823 standards.

Indications for Use

Indicated for dental patients requiring impressions for study models, restorative prosthetic devices, crown/bridgework, inlays, full/partial dentures, relines, and implant-related impressions. Used in various putty/wash, simultaneous, and functional impression techniques. Prescription use only.

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

• Panasil® Impression Materials (K954281)
• Aquasil Ultra Rigid Smart Wetting® Impression Materials (K021413)
• Aquasil Ultra XLV Smart Wetting® Impression Material (K021410)
• Kerr VPS Impression Material (K050604)

Submission Summary (Full Text)

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Traditional Premarket Notitication [510(K)] Panasil® Impression Materials

ບບການປະເທດລ

K082560

### 510(K) Summary

SEP 0 8 2008

| | SEP 08 2008 |
|--------------------------|-------------------------------------------------------------------|
| A. Submitter Information | |
| Submitter's Name: | Kettenbach GmbH & Co. KG |
| Address: | Im Heerfeld 7 |
| | D-35713 |
| | Eschenburg, Germany |
| Phone Number: | ([phone] |
| Fax Number: | ([phone] |
| Contact Person: | Michaela Zinke |
| Date of Preparation: | July 10, 2008 |
| B. Device Name | |
| Trade Name: | Panasil® Impression Materials, to include: |
| | • Panasil® putty (putty, putty fast set, putty soft) |
| | • Panasil® binetics (putty fast, putty soft) |
| | • Panasil® tray (fast, soft) |
| | • Panasil® monophase |
| | • Panasil® contact (two in one, plus) |
| Common/Usual Name: | Impression Material |
| Classification Name: | Material, Impression (21 CFR 872.3660, Product Code: ELW) |
| C. Predicate Devices | |
| Trade Name: | Panasil® Impression Materials (K954281) |
| Trade Name: | Aquasil Ultra Rigid Smart Wetting® Impression Materials (K021413) |
| Trade Name: | Aquasil Ultra XLV Smart Wetting® Impression |

Kerr VPS Impression Material (K050604)

Material (K021410)

Trade Name:

. .

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#### D. Device Description

Panasil® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Material family consists of five different viscosities (putty, heavy-bodied, medium-bodied, light-bodied, x-lightbodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge, 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.

### E. Intended Use

The Panasil® Impression Materials are intended to:

- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetic devices.

### Indications for Use

Panasil putty (putty, putty fast set, putty soft) and Panasil binetics (putty fast, putty soft) are to be used as preliminary materials for:

-Two step putty/wash impression technique.

-One step putty/wash impression technique.

- -Two step putty/wash impression technique using a foil (plastic putty spacer)
- -One step putty impression technique for forming functional peripheries.

Panasil trav (fast. soft) is to be used as a heavy-bodied material for:

- -One step impression technique (simultaneous technique) using single or dual viscosities.
- -Two step impression technique using dual viscosities.
- -Functional impressions.

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Panasil monophase is to be used as a medium-bodied tray or syringeable impression material for:

- -Taking impressions over fixed/removable restorations and implants
- (transferring impression posts and bridge components).
- -Functional impressions.
- -Fabricating crown and bridgework or inlays.
- -Fabricating full or partial dentures.
- -Reline impressions.
- -Use in the simultaneous mixing technique as well as the putty/wash and triple tray techniques.
- -Transferring root posts when fabricating posts and cores indirectly.

Panasil contact (two in one, plus) is to be used as a syringeable impression material for:

- -Two step putty/wash impression technique.
- -One step putty/wash impression technique.
- -One step impression technique using a foil (plastic putty spacer)
- -One step impression technique (simultaneous technique) using dual viscosities
- -Reline impressions.
- -Fabricating full or partial dentures.

### F. Technological Characteristics Summary

The technological characteristics of Panasil® Impression Materials are substantially equivalent to the predicate device technological characteristics. Panasil Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) and the predicate devices are addition-curing, elastomeric materials designed and manufactured for use as dental impression materials.

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#### G. Performance Data

No performance standards have been established for this type of device. Panasil® Impression Materials have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998) and ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007. The results of device performance testing demonstrated that Panasil Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) are suitable for use as dental impression materials. Panasil Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

SEP 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kettenbach GmbH & Company KG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K082560

Trade/Device Name: Panasil® Putty (Putty, Putty Fast Set, Putty Soft), Panasil® Binetics (Putty Fast, Putty Soft), Panasil® Tray (Fast, Soft), Panasil® Monophase, Panasil® Contact (Two in One, Plus) Regulation Number: 872.3660 Regulation Name: Partially Fabricated Denture Kit Regulatory Class: II Product Code: ELW Dated: September 2, 2008 Received: September 4, 2008

Dear Mr. Preiss:

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 - Mr. Preiss

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 CI'R 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 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 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.

Thhammelb. Lerdiner frell

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

Enclosure

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510(k) Number (if known): _ KO22560

Device Name: Panasil® putty (putty, putty fast set, putty soft),

Indications for Use:

Panasil putty (putty, putty fast set, putty soft) is to be used as a preliminary material for:

- -Two step putty/wash impression technique.
- -One step putty/wash impression technique.
- -Two step putty/wash impression technique using a foil (plastic putty spacer)
- -One step putty impression technique for forming functional peripheries.

| Prescription Use | X |
|-----------------------------|---|
| (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | 1082560 |
|----------------|---------|
|----------------|---------|

Page 1 of 5

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510(k) Number (if known): \$0825 60

Device Name: Panasil® binetics (putty fast, putty soft)

Indications for Use:

Panasil binetics (putty fast, putty soft) is to be used as a preliminary material for:

-Two step putty/wash impression technique.

-One step putty/wash impression technique.

-Two step putty/wash impression technique using a foil (plastic putty spacer)

- Two step putty/waon improberhnique for forming functional peripheries.

Prescription Use __ × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sina Ruom

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

Page 2 of 5

510(k) Number:

K082560

Page 17 of 510

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Panasil® tray (fast, soft)

Indications for Use:

### Panasil tray (fast, soft) is to be used as a heavy-bodied material for:

- -One step impression technique (simultaneous technique) using single or dual viscosities.
- -Two step impression technique using dual viscosities.
- -Functional impressions.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 3 of 5

510(k) Number:

Kattanhach GmhH & C.n KG

Page 18 of 510

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Panasil® monophase

Indications for Use:

### Panasil monophase is to be used as a medium-bodied tray or syringeable impression material for:

-Taking impressions over fixed/removable restorations and implants

(transferring impression posts and bridge components).

-Functional impressions.

- -Fabricating crown and bridgework or inlays.
-Fabricating full or partial dentures.

-Reline impressions.

-Use in the simultaneous mixing technique as well as the putty/wash and triple tray techniques.

-Transferring root posts when fabricating posts and cores indirectly.

Prescription Use × (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 IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runar

Division Sign-Off) )ivision of Anesthesiology, General Hospital nfection Control, Dental Devices

Page 4 of 5

10(k) Number: K082560

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510(k) Number (if known): _KOKAS (eC)

Device Name: Panasil® contact (two in one, plus)

Indications for Use:

Panasil contact (two in one, plus) is to be used as a syringeable impression material for:

- -Two step putty/wash impression technique.
- -One step putty/wash impression technique.
- -One step impression technique using a foil (plastic putty spacer)
- -One step impression technique (simultaneous technique) using dual viscosities
- -Reline impressions.
- -Fabricating full or partial dentures.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| Division Sign-Off) | |
|----------------------------------------------|---------|
| Division of Anesthesiology, General Hospital | |
| nfection Control, Dental Devices | |
| 510(k) Number: | K082560 |

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