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#
- 3003761382
- 3016458459
- 3004753334
- 3040999583
- 3008849197
- 3031841433
- 8041196
- 3011524638
- 3012133441
- 3017417635
- 3007113238
- 3017618900
- 3003423103
- 3033258462
- 3012187973
- 3005816808
- 3016447301
- 3008262609
- 3043476844
- 2438205
- 3005558160
- 3030671618
- 1000508490
- 3004069780
- 3013779301
- 3015217632
- 3014610038
- 3006639573
- 9615442
- 3004102507
- 3023339277
- 3003361112
- 2938386
- 3010864832
- 9680271
- 3014316197
- 3033911545
- 3003491259
- 3030228577
- 3013205789
- 1316367
- 9614443
- 3014045831
- 3011205500
- 3019912897
- 3011279497
- 9615431
- 9710651
- 3017751928
- 2529851
- 3008254143
- 3011888867
- 3010598169
- 3012041047
- 3017910185
- 3008274190
- 3008808560
- 3007336881
- 3010896988
- 3008887731
- 3014387063
- 3021368823
- 3033918991
- 2183301
- 3007502533
- 3004649039
- 3008925277
- 3013181914
- 3021460491
- 3012118920
- 3023895623
- 3030539818
- 3015168527
- 3007421127
- 3013123677
- 3014683120
- 3003487388
- 1051594
- 3007485188
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 |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Colgate-Palmolive Co. | 1995-04-27 |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | 1995-04-27 |
| K942690 | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K942689 | RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 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 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
Legacy Summary#
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FDA Review#
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