510(k) K770941
- Device
- APPLIC SYSTEM ACTIVATOR, ESPE
- Applicant
- Espe GmbH (Us)
- 510(k) number
- K770941
- Product code
- EID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-02
- Date received
- 1977-05-23
- Regulation
- 872.4565
- Classification name
- Syringe, Restorative And Impression Material
- 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#
- 3008922120
- 1410097
- 3027448274
- 9612352
- 1281412
- 3014268398
- 3003600526
- 2134751
- 1420052
- 3007353764
- 3014334038
- 3008729549
- 3007165189
- 3014150341
- 2431069
- 3038632739
- 3031841433
- 3006847937
- 9681356
- 3011434305
- 3008346537
- 2086043
- 3010147274
- 1051614
- 3011707926
- 2029234
- 3003829571
- 3009960170
- 9680954
- 3031582434
- 3025414363
- 3006694515
- 3012187973
- 3013020540
- 3043648115
- 3004992978
- 3005665377
- 3012354669
- 1064619
- 2918719
- 3002808270
- 3008770655
- 3005558160
- 3003169405
- 3011554142
- 3038285060
- 8021050
- 1215305
- 3009171220
- 8010908
- 1815540
- 3042866301
- 3011526299
- 2511556
- 3031886796
- 3003621174
- 3008582406
- 2024980
- 3015332784
- 3038718579
- 1313525
- 1836392
- 3004046477
- 9681210
- 3007113445
- 3003394081
- 3010864832
- 3032027578
- 2244812
- 2031508
- 3008966075
- 3027234828
- 3015045320
- 2515379
- 9614794
- 3016654925
- 3004143450
- 3011279497
- 9611367
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EID#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941431 | BONE GRAFT DELIVERY SYRINGES | Bio-Interfaces, Inc. | 1994-07-12 |
| K913974 | ACCESS IMPRESSION BARREL | Centrix, Inc. | 1992-02-25 |
| K873153 | CAULK'S VPS CARTRIDGE SYSTEM | Dentsply Intl. | 1987-09-16 |
| K871937 | IMPRESSION SYRINGE | Dentsply Intl. | 1987-06-05 |
| K863998 | COLTENE JET-MIXER | Coltene, Inc. | 1986-10-30 |
| K853282 | CENTRIX RIBBON TUBES | Centrix, Inc. | 1985-08-23 |
| K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | Unitek Corp. | 1985-04-29 |
| K812680 | G-C IMPRESSION SYRINGE | G-C Intl. Corp. | 1981-10-06 |
| K812277 | PRISMA-FIL COMPULES | Caulk Co., Div. Dentsply | 1981-09-08 |
| K811582 | THE PLACER | Cavitron Corp. | 1981-07-28 |
| K781977 | APPLICATOR, LEE IMPRESSION | Lee Pharmaceuticals | 1978-12-20 |
| K770931 | APPLIC SYSTEM APPLIER, ESPE | Espe GmbH (Us) | 1977-06-03 |