INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH
FDA 510(k) clearance K901928 · decided 1990-07-26
Clearance details
- K-number
- K901928
- Device name
- INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH
- Applicant
- Interpore Intl.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-27
- Decision date
- 1990-07-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EGG
- Device class
- 1
- Regulation number
- 872.3165
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Rockville, MD, 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 |
| 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 |
| COSMETIC SINGLE SPAN BRIDGE (K871439) | Cosmetic Dental Technologies, Inc. | 1987-06-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PRO OSTEON 500 BONE GRAFT SUBSTITUTE (P860005/S012) | Interpore Intl. | 2002-05-31 |
| PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES (P860005/S011) | Interpore Intl. | 1999-05-25 |
| PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES (P860005/S009) | Interpore Intl. | 1998-04-28 |
| PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE (P860005/S010) | Interpore Intl. | 1998-01-08 |
| PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S008) | Interpore Intl. | 1997-09-11 |
| PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S007) | Interpore Intl. | 1997-05-30 |
| PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S005) | Interpore Intl. | 1996-07-18 |
| INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX (P860005/S004) | Interpore Intl. | 1994-08-08 |