SPLINT IT

K972985 · Jeneric/Pentron, Inc. · ELS · Sep 24, 1997 · Dental

Device Facts

• Record ID: K972985
• Device Name: SPLINT IT
• Applicant: Jeneric/Pentron, Inc.
• Product Code: ELS · Dental
• Decision Date: Sep 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Splinting periodontially involved and mobile teeth to prevent movement. To reinforce full denture and partial denture repairs. As a matrix between abutinent teeth for receiving a temporary replacement tooth. As an aid in the reinforcament of temporary crowns and bridgework. As a space maintainer for orthodontically Involved teeth.

Device Story

Splint-It™ is a dental material used by clinicians to stabilize mobile teeth or reinforce dental prosthetics. It functions as a structural support or matrix in various restorative and orthodontic procedures. The device is applied chairside by dental professionals to provide mechanical reinforcement for temporary crowns, bridges, and dentures, or to maintain space between teeth. By splinting mobile teeth or acting as a reinforcement aid, it prevents unwanted movement and enhances the structural integrity of temporary dental appliances, ultimately supporting patient comfort and functional stability during treatment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental splinting and reinforcement material. Form factor and specific material composition not detailed in provided text. Non-electronic, mechanical support device.

Indications for Use

Indicated for patients requiring stabilization of periodontally involved/mobile teeth, reinforcement of denture repairs, temporary tooth replacement matrices, reinforcement of temporary crowns/bridges, and orthodontic space maintenance.

Regulatory Classification

Identification

An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

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Food and Orug Administration 9200 Corporate Boulevard Rockville MD 20850

K972985
24 SEP 97

Mr. Murray Gamberg Quality Systems Director Jeneric/Pentron, Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724

K972985 Re : Splint It™ Trade Name: Regulatory Class : II ELS Product Code: Dated: August 8, 1997 Received: August 11, 1997

Dear Mr. Gamberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional. controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Gamberg

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Clins. F/r
Timothy A. Ulatowski

Timothy A. Ulato Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enalosure

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K972985

Page 1 of 1

510(k) Number (if known): K972985

Device Name: Splint-I(™

Indications for Use

Splinting periodontially involved and mobile teeth to prevent movement.

To reinforce full denture and partial denture repairs.

As a matrix between abutinent teeth for receiving a temporary replacement tooth.

As an aid in the reinforcament of temporary crowns and bridgework

As a space maintainer for orthodontically Involved teeth.

## EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

(Division Sign-Off) Concurrence of SBRH-Office of Device Evaluation (ODE) Division of D and General Ho 510k Over-the-Counter Use _ CFR 801 (Optional Format 1/2/96)