510(k) K884145
- Device
- FLOSER PLUS
- Applicant
- PACIFIC LIN INTL., CO.
- 510(k) number
- K884145
- Product code
- JES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-19
- Date received
- 1988-10-03
- Regulation
- 872.6390
- Classification name
- Floss, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTOR LIN
- Address
- P.O. Box 3155 Alhambra CA US 91803 91803
FDA Registration Numbers#
- 3011524638
- 3014316197
- 3038181748
- 3017954358
- 8041196
- 3007502533
- 3010598169
- 3015553940
- 3027283275
- 3031180735
- 3003361112
- 3042534768
- 3014373983
- 3031224575
- 3012047097
- 3000268902
- 3030507585
- 3009827000
- 3003618527
- 9613415
- 3034278341
- 9680012
- 3042278984
- 2938386
- 8030607
- 3008343409
- 3006140792
- 3004776555
- 3030795695
- 3005980667
- 3042272797
- 2087561
- 3006130829
- 3008274190
- 3008328678
- 3007485188
- 3011545201
- 3017195494
- 3006113202
- 3004096300
- 3031841433
- 3014610038
- 3009495628
- 1413787
- 2032877
- 3008035828
- 3016458459
- 3033258462
- 3016447301
- 3014707731
- 2087362
- 3013735167
- 3010262284
- 3012133441
- 3016450032
- 3000099306
- 3019804885
- 2183301
- 2954286
- 3007113238
- 3020311844
- 3009566748
- 3008808560
- 3008808082
- 3013557562
- 1000634183
- 3028015088
- 3007663061
- 3015139713
- 3030671618
- 3010864832
- 3031288561
- 3013530901
- 1316367
- 3042277637
- 3017751928
- 3013561919
- 3015128224
- 3023895623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble Co. | 2009-09-24 |
| K964976 | FLOSSBRUSH WITH FLUORIDE | Flossbrush Interdental Cleaner and Applicator | 1997-05-06 |
| K963746 | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID | Whitehill Oral Technologies, Inc. | 1996-12-12 |
| K944034 | PERIO-MED DENTAL FLOSS | Whitehill Oral Technologies, Inc. | 1995-07-25 |
| K952091 | VUTLER G.U.M. WITH FLUORIDE | John O. Butler Co. | 1995-06-28 |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | Johnson & Johnson Consumer Products, Inc. | 1995-05-10 |
| K942689 | RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K942690 | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | 1995-04-27 |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Colgate-Palmolive Co. | 1995-04-27 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | 1994-02-03 |
| K935522 | RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE | Ranir/Dcp Corp. | 1994-01-26 |
| K931353 | FLOSS PLUS | Floss Plus, Inc. | 1993-07-27 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
Legacy Summary#
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FDA Review#
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