PARAGON
FDA 510(k) clearance K991481 · decided 1999-08-11
Clearance details
- K-number
- K991481
- Device name
- PARAGON
- Applicant
- Lancer Orthodontics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-28
- Decision date
- 1999-08-11
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- EJJ
- Device class
- 2
- Regulation number
- 872.3070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Marcos, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| SILVERFIL (K053114) | Dunia Perwira Manufacturing Sdn. Bhd. | 2005-11-15 |
| SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (K051010) | Septodont | 2005-05-02 |
| BESTALOY (K033434) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| BENCO ADMIX (K032152) | Southern Dental Industries, Inc. | 2003-08-06 |
| BENCO SPHERICAL (K031658) | Southern Dental Industries, Inc. | 2003-07-29 |
| HIGH SILVER CONVENTIONAL (K020452) | Ab Ardent | 2002-05-07 |
| FUTURA TOPCAP NON GAMMA-2 (K011801) | Ab Ardent | 2001-08-16 |
| ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (K002811) | Nordiska Dental AB | 2000-10-31 |
| ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (K002810) | Nordiska Dental AB | 2000-10-31 |
| ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (K002808) | Nordiska Dental AB | 2000-10-31 |
| SECURALLOY (K982671) | Specialites Septodont | 1998-10-19 |
| VIVACAP HR (K982460) | Ab Ardent | 1998-08-24 |
Recalls involving this device
No recalls on record reference this clearance.