510(k) K050318
- Device
- BARI-KAD PACKING DEVICE
- Applicant
- Bioenvelop Agro, Inc.
- 510(k) number
- K050318
- Product code
- EIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-04
- Date received
- 2005-02-09
- Regulation
- 872.6300
- Classification name
- Dam, Rubber
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBERT SCHIFF
- Address
- 1129 Bloomfield Ave. West Cadwell NJ US 07006 07006
FDA Registration Numbers#
- 8021853
- 3012421607
- 2183301
- 3005558160
- 3021023132
- 3004140838
- 3007210751
- 3008912871
- 3029507159
- 2939935
- 3013496867
- 1319130
- 2087259
- 2018957
- 9611959
- 3004966444
- 3010664129
- 3015527825
- 3007064566
- 2133714
- 3038718579
- 3009171220
- 2023950
- 9616065
- 3005791808
- 3004569445
- 8030938
- 3012312751
- 3011554142
- 2027062
- 3009496224
- 3010288346
- 3010245461
- 1424442
- 9611450
- 3026630
- 1215305
- 8010629
- 3015136927
- 3012041047
- 3043226252
- 8040881
- 2416455
- 3006367836
- 3021388085
- 3023155873
- 3014683120
- 3013584861
- 3015287618
- 3003600526
- 8041151
- 1836161
- 3012996495
- 3005497907
- 9613083
- 3030795695
- 3006113314
- 3013520830
- 9681338
- 3014314529
- 1519375
- 3014268398
- 1413475
- 3008524225
- 3012494290
- 3027320022
- 2523320
- 3025307990
- 3043648115
- 3008475975
- 3038632739
- 3003618527
- 2031532
- 3042586390
- 3007060769
- 3021076825
- 3022516928
- 3030126955
- 3020521811
- 3017910185
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182118 | armor LC | Mavrik Dental Systems, Ltd. | 2019-05-03 |
| K151945 | Triumph Resin Dam | Denali Corporation | 2016-02-18 |
| K043301 | GC TION GINGIVAL PROTECTOR | GC America, Inc. | 2005-01-25 |
| K040797 | BRITESMILE MASKING CREAM | Britesmile, Inc. | 2004-04-02 |
| K022522 | PULPDENT PUTTY DAM | Pulpdent Corporation | 2002-09-26 |
| K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. | 2002-07-19 |
| K021613 | NIVEOUS LIQUID DAM | Shofu Dental Corp. | 2002-06-20 |
| K010935 | BRITESMILE BARRIER MATERIAL | Britesmile, Inc. | 2001-09-05 |
| K983227 | POWER BLOCK | Kreativ, Inc. | 1998-12-11 |
| K972775 | FASTDAM | Interdent, Inc. | 1998-02-27 |
| K961472 | DENTAL DAM SILICONE | Worldwide Dental, Inc. | 1996-08-07 |
| K954990 | DENTAL DAM | The Hygenic Corp. | 1996-01-26 |
| K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | Elastomade Accessories Sdn Bhd | 1995-10-19 |
| K942992 | ROYAL SHIELD RUBBER DAMS | Elastomade Accessories Sdn Bhd | 1994-09-21 |
| K923157 | DENTAL RUBBER DAM | Aseptico, Inc. | 1993-07-22 |