T-IV ELITE ALLOY
FDA 510(k) clearance K820530 · decided 1982-03-19
Clearance details
- K-number
- K820530
- Device name
- T-IV ELITE ALLOY
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-01
- Decision date
- 1982-03-19
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- EJS
- Device class
- 2
- Regulation number
- 872.3060
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRIGHT GOLD XH (K041433) | Ivoclar Vivadent, Inc. | 2004-08-19 |
| SIMIDUR SUPERIOR (K040436) | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 |
| STERNGOLD 1, MODEL 1127781 (K022252) | Sterngold | 2002-09-19 |
| ECO E4 (K022469) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| STERNGOLD 66, MODEL #1180230 (K021367) | Sterngold | 2002-05-16 |
| SIMIDUR S1S (K020195) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| SIMIDUR S2 (K020192) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| SIMIDUR KF PLUS (K020194) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| D.SIGN 84 (K014042) | Ivoclar Vivadent, Inc. | 2002-02-22 |
| D.SIGN 59 (K013809) | Ivoclar Vivadent, Inc. | 2002-02-07 |
| D.SIGN 53, MODEL NA1012204 (K014082) | Ivoclar Vivadent, Inc. | 2002-01-30 |
| DUO PAL 6, ORDER-NO.: 2154 (K012841) | Wieland Edelmetalle GmbH & Co. | 2001-11-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |