BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE
FDA 510(k) clearance K003603 · decided 2001-01-10
Clearance details
- K-number
- K003603
- Device name
- BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE
- Applicant
- Jelenko Co.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-21
- Decision date
- 2001-01-10
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- EJT
- Device class
- 2
- Regulation number
- 872.3060
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Armonk, 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 |
|---|---|---|
| PROMETAL HN86 (K052463) | Prometal Technologies | 2005-10-14 |
| BIO 60 (K041378) | Kodent, Inc. | 2004-08-02 |
| PORTA REFLEX (K040672) | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 |
| PORTA SOLDER 1090 W (K040524) | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 |
| NDX-40 ALLOY (K040043) | Heraeus Kulzer, Inc. | 2004-03-03 |
| HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM (K034049) | Heraeus Kulzer,GmbH | 2004-03-01 |
| GOLD DENTAL CASTING ALLOYS (K033279) | Bego U.S.A. | 2004-01-15 |
| APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (K033446) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 |
| E-SARANG 86, DM78, DM55 (K033435) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| APPOLLO 3 ALLOY (K032320) | Dentsply International | 2003-10-01 |
| ORION GX ALLOY (K032317) | Dentsply Intl. | 2003-09-30 |
| CERA R PLUS ALLOY (K032319) | Dentsply International | 2003-09-30 |
Recalls involving this device
No recalls on record reference this clearance.