← Product Code [EIE](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE) · K961472 # DENTAL DAM SILICONE (K961472) _Worldwide Dental, Inc. · EIE · Aug 7, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE/K961472 ## Device Facts - **Applicant:** Worldwide Dental, Inc. - **Product Code:** [EIE](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE.md) - **Decision Date:** Aug 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6300 - **Device Class:** Class 1 - **Review Panel:** Dental ## Indications for Use The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. ## Device Story Silicone dental dam; 150 mm x 150 mm green opaque film; <1mm thickness. Used as physical barrier for tooth isolation during dental procedures. Inserted into oral cavity via hole punched in sheet; secured with frame and clamp accessories. Provides alternative for latex-allergic patients and clinicians. Benefits include biocompatibility and slow aging process compared to latex. ## Clinical Evidence Bench testing only; biocompatibility testing performed to assess biological response. ## Technological Characteristics Polymerized silicone film; contains catalyst and coloring agent. Dimensions: 150 mm x 150 mm; thickness <1mm. Physical properties (elongation) comparable to latex. Non-latex material composition. ## Regulatory Identification A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter. ## Predicate Devices - Hygienic brand latex dam ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K 961472 AUG - 7 1996 510(k)Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. 1. The submitter of this premarket notification is: Karen K. Vaccaro, Ph.D. EXPERTech™ Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742-5307 Telephone: (508) 371-0066 Fax: (508) 371-1676 This Summary was prepared on July 24, 1996. 2. The name of the device is Roeko Dental Dam Silicone. Its common name is dental dam and the classification name is Rubber dam and accessories. 3. The Roeko Silicone Dental Dam is substantially equivalent to the Hygienic brand latex dam. 4. The Roeko dam is a silicone product used in dental procedures. The device consists of a 150 mm x 150 mm green opaque film of less than 1mm in thickness. The device is available with frame, clamp and other accessories for use in dental procedures. 5. The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device. 6. The technological characteristics in terms of physical properties, particularly elongation, are comparable to latex; however, the aging process is very slow, if at all. Chemically, the Roeko dental dam is composed of polymerized silicone rather than latex and contains a catalyst and coloring agent. Biocompatibility tests indicate that Roeko Dental Dam Silicone does not show significantly adverse biological responses. Patients with a latex allergy can now be treated with a silicone dental dam and dentists allergic to latex are able to treat patients with a silicone dental dam. In view of the above, the device is as safe, as effective and performs as well or better than the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE/K961472](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE/K961472) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com