THE GNATOMET
FDA 510(k) clearance K810971 · decided 1981-05-05
Clearance details
- K-number
- K810971
- Device name
- THE GNATOMET
- Applicant
- Bauer, Cheng & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-09
- Decision date
- 1981-05-05
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- EJP
- Device class
- 1
- Regulation number
- 872.3150
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALRAND INC. (DENTAL HAND INSTRUMENTS) (K926190) | Alrand, Inc. | 1994-01-18 |
| GNATHOMAT ARTICULATOR (K896131) | Ivoclar North America, Inc. | 1989-12-04 |
| DENTAL PLASTIC BITE FORK (K892373) | Texapol Corp. | 1989-06-12 |
| PREMIER DIE-TRAK ARTICULATOR (K884418) | Premier Medical | 1988-11-14 |
| DISPOSABLE ARTICULATOR (K872943) | Dentsply Intl. | 1987-08-11 |
| GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (K863009) | Sds Dental, Inc. | 1986-09-25 |
| PLASTIC MOUNTING RINGS (K854702) | Almore Intl., Inc. | 1986-03-06 |
| HANDY IIM (K833039) | Shofu Dental Corp. | 1983-10-04 |
| BALANCE ARTICULATOR (K811075) | Almore Intl., Inc. | 1981-05-13 |
| DISPOSABLE ARTICULATOR (K801342) | Williams Gold Refining Co., Inc. | 1980-07-08 |
Recalls involving this device
No recalls on record reference this clearance.