Pin, Retentive And Splinting, And Accessory Instruments
The Retentive and Splinting Pin and Accessory Instruments are dental devices used to place small metallic pins into dentin to improve the retention of large restorations, or to splint multiple teeth together, along with the hand instruments used to insert and trim these pins. They are classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EBL and the applicable regulation is 21 CFR 872.3740, under the Dental medical specialty.
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Basic Information
- Product Code
- EBL
- Device Class
- FDA class 1
- Regulation Number
- 872.3740
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K002693 | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Nov 09, 2000 | Substantially Equivalent | Cbs Intl. B.V. |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | Jul 19, 1995 | Substantially Equivalent | Dentauraum, Inc. |
| K924376 | ROOT CANAL POST | Nov 22, 1993 | Substantially Equivalent | The Thera Group |
| K895283 | PROSTHETIC RESTORATION DEVICE | Feb 14, 1990 | Substantially Equivalent | Swiss Precision Mfg. Corp. |
| K895758 | PLASTIC TOOTH REINFORCEMENT KIT | Dec 20, 1989 | Substantially Equivalent | Nanzee Dental Products |
| K883074 | ELGILOY | Aug 09, 1988 | Substantially Equivalent | Dale T. Dupuis |
| K863831 | VIVADENT FILPIN | Oct 14, 1986 | Substantially Equivalent | Vivadent (Usa), Inc. |
| K844457 | SECURIPIN | Dec 27, 1984 | Substantially Equivalent | Hughes Int'L, Inc. |
| K830773 | MARKLEY THREADED WIRE | Apr 28, 1983 | Substantially Equivalent | Almore Intl., Inc. |
| K822412 | REINFORCING PIN | Aug 30, 1982 | Substantially Equivalent | Filhol |
| K760723 | SAFE-T-PINS RETENTIVE PIN SYSTEM | Oct 21, 1976 | Substantially Equivalent | Parkell, Inc. |
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.