EIE · Dam, Rubber
Dental · 21 CFR 872.6300 · Class 1
Overview
| Product Code | EIE |
|---|---|
| Device Name | Dam, Rubber |
| Regulation | 21 CFR 872.6300 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182118 | armor LC | Mavrik Dental Systems, Ltd. | May 3, 2019 | SESE |
| K151945 | Triumph Resin Dam | Denali Corporation | Feb 18, 2016 | SESE |
| K050318 | BARI-KAD PACKING DEVICE | Bioenvelop Agro, Inc. | Mar 4, 2005 | SESE |
| K043301 | GC TION GINGIVAL PROTECTOR | GC America, Inc. | Jan 25, 2005 | SESE |
| K040797 | BRITESMILE MASKING CREAM | Britesmile, Inc. | Apr 2, 2004 | SESE |
| K022522 | PULPDENT PUTTY DAM | Pulpdent Corporation | Sep 26, 2002 | SESE |
| K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. | Jul 19, 2002 | SESE |
| K021613 | NIVEOUS LIQUID DAM | Shofu Dental Corp. | Jun 20, 2002 | SESE |
| K010935 | BRITESMILE BARRIER MATERIAL | Britesmile, Inc. | Sep 5, 2001 | SESE |
| K983227 | POWER BLOCK | Kreativ, Inc. | Dec 11, 1998 | SESE |
| K972775 | FASTDAM | Interdent, Inc. | Feb 27, 1998 | SESE |
| K961472 | DENTAL DAM SILICONE | Worldwide Dental, Inc. | Aug 7, 1996 | SESE |
| K954990 | DENTAL DAM | The Hygenic Corp. | Jan 26, 1996 | SESE |
| K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | Elastomade Accessories Sdn Bhd | Oct 19, 1995 | SESE |
| K942992 | ROYAL SHIELD RUBBER DAMS | Elastomade Accessories Sdn Bhd | Sep 21, 1994 | SESE |
| K923157 | DENTAL RUBBER DAM | Aseptico, Inc. | Jul 22, 1993 | SESE |
| K923163 | RUBBER DAM CLAMP | Aseptico, Inc. | Dec 28, 1992 | SESE |
| K921771 | MINIDAM II | Delsan Dental Systems | Sep 17, 1992 | SESE |
| K905470 | STANDARD RUBBER DAM WITH OR WITHOUT FRAMES | Elastomade Accessories Sdn Bhd | Apr 25, 1991 | SESE |
| K901236 | RUBBER, DENTAL DAM (NON-STERILE) | Naturub Sdn. Bhd. | Jun 6, 1990 | SESE |
Top Applicants
- Aseptico, Inc. — 3 clearances
- Elastomade Accessories Sdn Bhd — 3 clearances
- Britesmile, Inc. — 2 clearances
- Dental Dam, Inc. — 2 clearances
- The Hygenic Corp. — 2 clearances
