Wire, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (30 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in DZC
| Company | 510(k)s | Recalls |
|---|---|---|
| Highland Metals | 7 | 2 |
| Ultimate Wireforms, Inc. | 5 | 0 |
| Gac Intl., Inc. | 3 | 0 |
| A Company, Inc. | 2 | 0 |
| Berkley and Co. | 2 | 0 |
| Dentauraum, Inc. | 2 | 0 |
| Flexmedics | 2 | 0 |
| Ormco Corp. | 1 | 1 |
| Albert J. Anthony, Dmd | 1 | 0 |
| Arthur L. Wool | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2011 | K112640 | HYPERELASTIC WIRE Ormco Corp. | DZC |
| Oct 5, 1994 | K943334 | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT Jay H. Geller | DZC |
| May 18, 1994 | K935638 | NITINOL, NITI Highland Metals | DZC |
| Feb 4, 1994 | K935140 | DENTAURUM STEEL LIGATURE WIRES Dentauraum, Inc. | DZC |
| Jan 31, 1994 | K935142 | DENTAURUM WIRES Dentauraum, Inc. | DZC |
| Jan 21, 1994 | K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE Flexmedics | DZC |
| Nov 19, 1993 | K933374 | NITI COIL SPRINGS Highland Metals | DZC |
| Nov 16, 1993 | K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER Highland Metals | DZC |
| Nov 12, 1993 | K933380 | REVERSE SURVE NITI ARCH WIRE Highland Metals | DZC |
| Nov 12, 1993 | K933379 | STAINLESS STEEL ARCHES Highland Metals | DZC |
| Nov 12, 1993 | K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER Highland Metals | DZC |
| Nov 12, 1993 | K933376 | NITI ARCH WIRE ON A SPOOL Highland Metals | DZC |
| Jul 28, 1993 | K931631 | COATED ORTHODONTIC DEVICES Wonder Wire | DZC |
| May 27, 1993 | K930202 | TITAN SEPARATING SPRING Ortho Spectrum, Inc. | DZC |
| Mar 31, 1993 | K924805 | ORTHODONTIC ARCH WIRE Ultimate Wireforms, Inc. | DZC |
| Mar 31, 1993 | K923837 | DIMPLED MULTI MODULUS ARCH WIRE Ultimate Wireforms, Inc. | DZC |
| Dec 23, 1992 | K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING Ultimate Wireforms, Inc. | DZC |
| Dec 4, 1992 | K923838 | THE ULTIMATE RCS ARCH WIRE Ultimate Wireforms, Inc. | DZC |
| Nov 4, 1992 | K920905 | BIOFORCE WIRE Gac Intl., Inc. | DZC |
| Oct 15, 1992 | K923839 | NITINOL GENTLE TOUCH COIL SPRING Ultimate Wireforms, Inc. | DZC |
| Aug 24, 1992 | K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE Gac Intl., Inc. | DZC |
| Nov 24, 1986 | K863742 | FLEXMEDICS NITINOL ARCH WIRE Flexmedics | DZC |
| Oct 31, 1985 | K852975 | INTERPORE 200 POROUS HYDROXYAPATITE Inrterpore Intl. | DZC |
| Jun 5, 1985 | K851878 | A COMPANY BRASS SEPARATING RINGS A Company, Inc. | DZC |
| May 9, 1985 | K851055 | SENTINOL -ORTHODONTIC ARCH WIRE Gac Intl., Inc. | DZC |
| Dec 3, 1984 | K843171 | FILAFEX TM, ESTHETIC ORTHODONTIC WIRE Berkley and Co. | DZC |
| Nov 9, 1984 | K843722 | ORTHODONTIC WIRE Arthur L. Wool | DZC |
| Jun 27, 1984 | K841638 | ALINE ORTHODONTIC ARCHWIRE A Company, Inc. | DZC |
| Jan 24, 1984 | K833788 | FILAFEX ESTHETIC ORTHODINIC WIRE Berkley and Co. | DZC |
| Sep 23, 1981 | K812454 | PAC-AID Albert J. Anthony, Dmd | DZC |
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