510(k) K770642
- Device
- SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE
- Applicant
- National Patent Development Corp.
- 510(k) number
- K770642
- Product code
- EIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-15
- Date received
- 1977-04-04
- Regulation
- 872.4565
- Classification name
- Syringe, Periodontic, Endodontic, Irrigating
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3016658851
- 3007255375
- 9615399
- 3004168759
- 2515379
- 3027344570
- 3003882387
- 3008887731
- 3011371465
- 3013552516
- 3004046477
- 1066741
- 3011463882
- 3038718579
- 1017768
- 9614075
- 3009049852
- 3010131268
- 3021666757
- 3007353764
- 1423537
- 3009420946
- 3003700106
- 1043214
- 8010414
- 8010732
- 3006444232
- 3008493350
- 9614573
- 3045855232
- 3044819802
- 8010629
- 9680244
- 9610612
- 3006891796
- 9611062
- 9681851
- 3027605742
- 3004784004
- 3035708926
- 3011526299
- 9613073
- 3015526995
- 3012305175
- 1032347
- 3015142372
- 3009768364
- 1055236
- 3006845489
- 3012322979
- 3010864832
- 3006313979
- 3005841027
- 3012101664
- 3017609565
- 9614069
- 3033011342
- 3005813597
- 3008352964
- 3007773213
- 3011707926
- 3014683120
- 3015491448
- 3002769844
- 3003969055
- 1018470
- 3006264569
- 3009255580
- 3003487388
- 1718912
- 3008722033
- 1054241
- 3025414363
- 3006608997
- 2183301
- 3005972890
- 8043792
- 2086043
- 3003877407
- 3013946322
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972234 | RCT GEL ROOT CANAL THERAPY GEL | Dentsply Intl. | 1997-06-30 |
| K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Smith & Nephew, Inc. | 1986-11-18 |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Solar Dental Co., Inc. | 1986-06-26 |
| K851944 | MAX-I-PROBE HANDPIECE | Solo Pak Laboratories | 1985-07-01 |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division | 1984-04-05 |
| K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. | 1981-07-24 |
| K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design | 1981-07-15 |
| K801483 | MARK IV SYRINGE | National Patent Development Corp. | 1980-07-21 |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | National Patent Development Corp. | 1980-07-21 |
| K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. | 1980-01-04 |
| K792578 | EPIC CANNULA | Dental Development Services, Inc. | 1980-01-04 |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. | 1979-12-19 |
| K771406 | GUTTA GUN | Aus-Tex Dental Mfg. & Design | 1977-08-26 |
| K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | National Patent Development Corp. | 1977-06-20 |
| K770813 | ENDOGATOR | Aus-Tex Dental Mfg. & Design | 1977-05-20 |