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#
- 8021050
- 3015136927
- 3000892153
- 2022039
- 3004143450
- 3003775534
- 3011707926
- 3004425647
- 2029234
- 3011526299
- 9680845
- 3015491448
- 1032227
- 2244812
- 2023950
- 9611367
- 1051614
- 3013020540
- 9612352
- 2511556
- 2183301
- 3010864832
- 3031841433
- 3038632739
- 2241860
- 8044164
- 3038718579
- 3004992978
- 3009420946
- 3003829571
- 3015045320
- 3004046477
- 3007165189
- 3008922120
- 3027234828
- 3010583458
- 2133714
- 3026326493
- 1064619
- 2249852
- 2031508
- 1215305
- 1000486347
- 3011434305
- 3030644259
- 1410097
- 3009960170
- 3005405146
- 9680954
- 3013463240
- 3014150341
- 3004966444
- 9611385
- 3023443842
- 3031886796
- 3009219448
- 3012477813
- 1932180
- 1281412
- 3042244574
- 3010147274
- 3003768919
- 8040278
- 1450653
- 3031582434
- 8020994
- 3014615644
- 3009496224
- 2014676
- 2523320
- 2431069
- 3017248108
- 3011210208
- 3042866301
- 3014683120
- 3004082121
- 3017352116
- 1000179416
- 2134751
- 3038191347
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 |