510(k) K822412
- Device
- Reinforcing Pin
- Applicant
- FILHOL
- 510(k) number
- K822412
- Product code
- EBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-30
- Date received
- 1982-08-10
- Regulation
- 872.3740
- Classification name
- Pin, Retentive And Splinting, And Accessory Instruments
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1044031
- 3003120666
- 1000303432
- 3038718579
- 3005698174
- 3004425647
- 3008346537
- 3006542438
- 1215305
- 9611274
- 8044177
- 8030870
- 3009488939
- 3005176727
- 2435118
- 9612278
- 1424785
- 3004139812
- 3003399707
- 1836161
- 3012322979
- 3008912871
- 3013846070
- 3003491259
- 3011554142
- 2416455
- 9680518
- 9613926
- 3012421607
- 3033085428
- 1032227
- 3003882387
- 3015136927
- 3003487388
- 3013011598
- 3007587775
- 3010152557
- 3009171220
- 3009611645
- 3012494290
- 3030531648
- 9616246
- 2025918
- 3003402534
- 3021076825
- 3031240334
- 9616119
- 1222993
- 3024547982
- 9611458
- 3005972890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002693 | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Cbs Intl. B.V. | 2000-11-09 |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | Dentauraum, Inc. | 1995-07-19 |
| K924376 | ROOT CANAL POST | The Thera Group | 1993-11-22 |
| K895283 | PROSTHETIC RESTORATION DEVICE | Swiss Precision Mfg. Corp. | 1990-02-14 |
| K895758 | PLASTIC TOOTH REINFORCEMENT KIT | Nanzee Dental Products | 1989-12-20 |
| K883074 | ELGILOY | Dale T. Dupuis | 1988-08-09 |
| K863831 | VIVADENT FILPIN | Vivadent (Usa), Inc. | 1986-10-14 |
| K844457 | SECURIPIN | Hughes Int'L, Inc. | 1984-12-27 |
| K830773 | MARKLEY THREADED WIRE | Almore Intl., Inc. | 1983-04-28 |
| K760723 | SAFE-T-PINS RETENTIVE PIN SYSTEM | Parkell, Inc. | 1976-10-21 |