JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD

K100653 · Lang Dental Mfg. Co., Inc. · EBI · Oct 8, 2010 · Dental

Device Facts

• Record ID: K100653
• Device Name: JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
• Applicant: Lang Dental Mfg. Co., Inc.
• Product Code: EBI · Dental
• Decision Date: Oct 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

LANG DENTAL Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based acrylic appliances and used wherever a radiopague acrylic dental device is useful in establishing an anatomical location or site, such as a provisional implant stent

Device Story

Jet XR is a self-curing, 2-part dental resin system consisting of a powder polymer and liquid monomer. It is used by dental professionals to fabricate methacrylate-based acrylic appliances. The device incorporates Barium Sulfate into the resin matrix to provide radiopacity, allowing the appliance to be visualized on diagnostic imaging to establish anatomical locations or sites, such as during the placement of provisional implant stents. The device is prepared by mixing the powder and liquid components, which then cure into a hard finished product. By providing radiopaque markers, the device assists clinicians in diagnostic planning and surgical positioning, potentially improving the accuracy of implant placement and other dental procedures.

Clinical Evidence

No clinical data was submitted. Substantial equivalence is supported by the identical chemical composition to the predicate device and the established biocompatibility of the added Barium Sulfate. Bench testing was performed to verify physical properties (flexural strength, modulus, sorption, solubility).

Technological Characteristics

Self-curing 2-part methacrylate-based acrylic resin system (powder polymer and liquid monomer). Contains Barium Sulfate as a radiopaque additive. Class II dental device. No specific ASTM standards cited for the material.

Indications for Use

Indicated for the fabrication of methacrylate-based acrylic dental appliances requiring radiopacity to establish anatomical location or site, such as provisional implant stents.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• OrthoJet Acrylic Resin (K941925)

Submission Summary (Full Text)

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# 1100653

## 510k Summary

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Prepared: July 21, 2010

# OCT 8 2010

## Submitted By:

Daniel J. Parrilli, Consultant c/o Lang Dental Manufacturing Co 175 Messner Dr P.O. Box 969 Wheeling. IL 60090-0969 815.814.2670 [e-mail]

## Contact:

David Lang, President Lang Dental Manufacturing Co. 175 Messner Drive P.O. Box 969 Wheeling, IL 60090-0969 [phone] x227 [e-mail]

Device Name: Denture relining, repairing, or rebasing resin Trade Name: Jet XR Common Name: Radiopaque Acrylic Resin Classification Name: Dental Product Classification: Class II Product Code: EBI

Predicate: OrthoJet Acrylic Resin (manufactured by Lang Dental-Manufacturing Co., Inc., a post-amendment device, K941925

Predicate Description: Intended for the fabrication of removable orthodontic PMMA appliances.

Statement of Intended Use: Jet XR Radiopague Acrylic Resin is intended for the fabrication of methacrylatebased acrylic appliances and used wherever a radiopaque acrylic" device is useful in establishing an anatomical location or site, such as a provisional implant stent 5

## Technological Characteristics: .

Summary of Similarities: Jet XR and OrthoJet are of exactly the same methyl Methacrylate resin compound. Summary of Dissimilarities: Jet XR has added to the Ortholet compound Barium Sulfate in

two variant concentrations to provide radiopacity in two separate levels to accomplish the diagnostic benefit J

# Performance Data:

# Non-Clinical Data Submitted and Referenced:

Physical property tests were conducted in a laboratory setting to test for adequate flexural strength and modulus as well as sorption and solubility as has been practice with other provisional acrylic products even though no ISO or ADA standards exist for provisional restorative or diagnostic products. Given that this product is not under stress in provisional or diagnostic applications, the performance characteristics appeared adequate.

#### Data Submitted and Referenced: Clinical

No clinical data was submitted as the chemical composition was identical to the predicate product excepting the addition of Barium Sulfate which has established biocompatibility. Conclusion that data demonstrates SE:

As the product is designed for diagnostic purposes and because it is of identical chemical composition to the predicate product except for the addition of the biocompatible radiopaque Barium Sulfate, this product is substantially equivalent.

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# PRODUCT DESCRIPTION

Lang Dental Jet XR Radiopaque Acrylic Resin is a high quality self curing 2-part system. The system is formed by a powder polymer and liquid monomer. The combination of powder polymer and liquid monomer is converted into a hard methacrylate finished product.

Lang Dental Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based actylic appliances that require radiopacity.

Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based acrylic appliances and used wherever a radiopaque acrylic dental device is useful in establishing an anatomical location or site, such as a provisional implant stent 7

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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Mr. David Lang President Lang Dental Manufacturing Company 175 Messner Drive P.O. Box 969 Wheeling, Illinois 60090-0969

# OCT 8 2010

Re: K100653

Trade/Device Name: Lang Dental Jet XR Radiopaque Acrylic Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 27, 2010 Received: September 29, 2010

Dear Mr. Lang:

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. 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.

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# Page 2- Mr. Lang

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh fo

Anthony D. Watson, B.S., M.S., M.B.A. 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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# INDICATIONS FOR USE

510(k) Number (if known):ג' נצ'ר ב-100 און): 510

Device Name: Lang Dental Jet XR Radiopaque Acrylic Resin

Indications for Use:

LANG DENTAL Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based acrylic appliances and used wherever a radiopague acrylic dental device is useful in establishing an anatomical location or site, such as a provisional implant stent

Prescription Use *X*
(21 CFR part 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

*Susa Rupe*
(Division Sign-Off)
Division of Anesthesiology, General Hospital
tion Control, Dental Devices

510(k) Number: A-11

Division of Antonious - Onfection Control.