DISTAFLEX
FDA 510(k) clearance K823280 · decided 1982-11-22
Clearance details
- K-number
- K823280
- Device name
- DISTAFLEX
- Applicant
- Duradent Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-03
- Decision date
- 1982-11-22
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- EGG
- Device class
- 1
- Regulation number
- 872.3165
- 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 |
|---|---|---|
| STECO-TITANMAGNETICS (K990979) | Steco-System-Technik GmbH & Cokg | 1999-09-03 |
| COUPLING DEVICE FOR DENTAL PROSTHESIS (K950259) | Dr. Joseph E. Grasso, D.D.S. | 1996-12-06 |
| ZEST ANCHOR ADVANCED GENERATION (K925700) | Zest Anchors, Inc. | 1994-04-07 |
| COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (K915299) | Cogan Corp. | 1992-01-31 |
| DENTAL CONNECTOR PRECISION ATTACHMENT (K912435) | Metalor Dental USA Corp. | 1991-08-28 |
| CONICAST, INTRACAST, OMECAST (K912567) | Metalor Dental USA Corp. | 1991-07-02 |
| INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH (K901928) | Interpore Intl. | 1990-07-26 |
| MICRO 2 SYSTEM (K900785) | Inodent | 1990-04-16 |
| DENTAL BRIDGE ANCHORING PINS (K896337) | Gayso Bridge-Tech, Inc. | 1990-01-31 |
| PRECISION DENTAL ATTACHMENTS (K895986) | Implant Support Systems, Inc. | 1989-10-18 |
| T.R.S.: TOOTH REPLACEMENT SYSTEM (K891119) | Health Technology of America, Inc. | 1989-04-17 |
| MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER (K882063) | Zest Anchors, Inc. | 1988-06-13 |
Recalls involving this device
No recalls on record reference this clearance.