Paper, Articulation
The Articulation Paper is a thin, ink-impregnated paper used in dentistry to identify and mark points of occlusal contact between upper and lower teeth, enabling the clinician to adjust restorations and natural tooth contacts for correct bite balance. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EFH and the applicable regulation is 21 CFR 872.6140, under the Dental medical specialty.
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Basic Information
- Product Code
- EFH
- Device Class
- FDA class 1
- Regulation Number
- 872.6140
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K965026 | PFINGST PRESSURE PASTE | Feb 10, 1997 | Substantially Equivalent | Pfingst & Co., Inc. |
| K912632 | OCCLUDE | Jan 17, 1992 | Substantially Equivalent | Pascal Co., Inc. |
| K911259 | HYDENT | Jun 06, 1991 | Substantially Equivalent | Pascal Co., Inc. |
| K864572 | FIXTECTOR | Feb 12, 1987 | Substantially Equivalent | Prodent Intl., Inc. |
| K870032 | REVISED T-SCAN SYSTEM | Feb 02, 1987 | Substantially Equivalent | Sentek, Inc. |
| K832647 | ARTICULATING PAPER | Feb 21, 1984 | Substantially Equivalent | Ardent Intl., Inc. |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Feb 10, 1984 | Substantially Equivalent | Myo-Tronics Research, Inc. |
| K810498 | CENTRIC (BITE) REGISTRATION PASTE | Mar 17, 1981 | Substantially Equivalent | Wallace A. Erickson & Co. |
| K771011 | ARTICULATING PAPER | Jun 20, 1977 | Substantially Equivalent | Parker Laboratories, Inc. |
| K770492 | CRACK DETECTOR, DEN-MAT | Mar 21, 1977 | Substantially Equivalent | Dey-Mat, Inc. |
FEI Numbers
This FDA classification entry is associated with 65 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 65 registration numbers. Click on an entry to view related FDA registrations.