510(k) K792461
- Device
- CENTRIX MKIV ENDODONTIC DELIVERY
- Applicant
- CENTRIX, INC.
- 510(k) number
- K792461
- Product code
- EIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-19
- Date received
- 1979-12-03
- Regulation
- 872.4565
- Classification name
- Syringe, Periodontic, Endodontic, Irrigating
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8010414
- 3012421607
- 2183301
- 3011463882
- 9614084
- 1032347
- 3003882387
- 3006264569
- 3043047788
- 3009703496
- 2245654
- 3004168759
- 3036269993
- 3006542438
- 3007064566
- 3005841027
- 2133714
- 3007751820
- 3016658851
- 1064619
- 3008722033
- 3038718579
- 3007353764
- 9611612
- 3009171220
- 3002807115
- 3017352116
- 8031010
- 1066741
- 3003700106
- 1017768
- 3003829571
- 8010732
- 9611062
- 9615399
- 3011434305
- 8010629
- 3010583458
- 3013946322
- 8040881
- 3003969055
- 2416455
- 3024787345
- 3007773213
- 3025414363
- 9611283
- 3009768364
- 3014683120
- 3013557562
- 3010864832
- 3006608997
- 8040278
- 3006444232
- 3009340886
- 3024088964
- 2437780
- 3008352964
- 3012305175
- 3013552516
- 3006891796
- 9614069
- 1836161
- 1055236
- 3027344570
- 3014150341
- 8010468
- 3003644849
- 3012101664
- 3008370577
- 3003487388
- 3017498782
- 9614726
- 3027605742
- 3015142372
- 3004784004
- 3006845489
- 3002769844
- 3000126234
- 3015491448
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 |
| 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 |
| K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | National Patent Development Corp. | 1977-04-15 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases