BRACE (ORAFIX SPECIAL)
FDA 510(k) clearance K890290 · decided 1989-03-29
Clearance details
- K-number
- K890290
- Device name
- BRACE (ORAFIX SPECIAL)
- Applicant
- Norcliff Thayer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-19
- Decision date
- 1989-03-29
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- ECB
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (K942519) | Bull Frog Mfg. Co. | 1994-08-23 |
| SURETIP SYRINGE TIP COVER (K931772) | Western M/D, Inc. | 1994-03-07 |
| DENTAL SYRINGE TIP (K931137) | A-Dec, Inc. | 1993-11-29 |
| RISKONTROL SINGLE USE (K923876) | Riskontrol | 1993-04-05 |
| PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (K923285) | Smith & Nephew, Inc. | 1992-09-15 |
| SANI-TIP (K920499) | Dw Industries, Inc. | 1992-05-03 |
| POSTERIOR NASAL EPISTAXIS INSTRUMENTS (K911756) | Richard Wolf Medical Instruments Corp. | 1991-10-24 |
| SERINGA TRIPLICE S.L. (K863024) | Sds Dental, Inc. | 1986-09-25 |
| TUBING SYRING (K854699) | Almore Intl., Inc. | 1986-01-06 |
| SPACELINE THREE WAY SYRINGE (K801686) | Pacific Dental Corp. | 1980-08-04 |
| DENTAL WARM WATER IRRIGATING SYSTEM (K781594) | Rama Corp. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.