EFH · Paper, Articulation
Dental · 21 CFR 872.6140 · Class 1
Overview
| Product Code | EFH |
|---|---|
| Device Name | Paper, Articulation |
| Regulation | 21 CFR 872.6140 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
Articulation paper is a device composed of paper coated with an ink dye intended to be placed between the patient's upper and lower teeth when the teeth are in the bite position to locate uneven or high areas.
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 the limitations in § 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.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K965026 | PFINGST PRESSURE PASTE | Pfingst & Co., Inc. | Feb 10, 1997 | SESE |
| K912632 | OCCLUDE | Pascal Co., Inc. | Jan 17, 1992 | SESE |
| K911259 | HYDENT | Pascal Co., Inc. | Jun 6, 1991 | SESE |
| K864572 | FIXTECTOR | Prodent Intl., Inc. | Feb 12, 1987 | SESE |
| K870032 | REVISED T-SCAN SYSTEM | Sentek, Inc. | Feb 2, 1987 | SESE |
| K832647 | ARTICULATING PAPER | Ardent Intl., Inc. | Feb 21, 1984 | SESE |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. | Feb 10, 1984 | SESE |
| K810498 | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. | Mar 17, 1981 | SESE |
| K771011 | ARTICULATING PAPER | Parker Laboratories, Inc. | Jun 20, 1977 | SESE |
| K770492 | CRACK DETECTOR, DEN-MAT | Dey-Mat, Inc. | Mar 21, 1977 | SESE |
Top Applicants
- Pascal Co., Inc. — 2 clearances
- Wallace A. Erickson & Co. — 1 clearance
- Sentek, Inc. — 1 clearance
- Prodent Intl., Inc. — 1 clearance
- Pfingst & Co., Inc. — 1 clearance
