510(k) K871937
- Device
- Impression Syringe
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K871937
- Product code
- EID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-05
- Date received
- 1987-05-18
- 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
- No
Applicant Contact#
- Contact
- JOHN O SEMMELMAN
- Address
- 570 W. College Ave. P.O. Box 872 York PA US 17405 17405
FDA Registration Numbers#
- 3005665377
- 1051614
- 3038285060
- 3027234828
- 3004362235
- 1410097
- 2029234
- 2437780
- 1032227
- 3011210208
- 3004046477
- 3017352116
- 3000892153
- 3024946194
- 3043648115
- 3010583458
- 3009420946
- 1450653
- 3011526299
- 3027448274
- 3010864832
- 3042866301
- 3010656982
- 1313525
- 3006694515
- 1066741
- 8040278
- 3008770655
- 3007165189
- 2249852
- 9611367
- 3031841433
- 3016654925
- 2133714
- 3004966444
- 3003600526
- 9612352
- 3012187973
- 3014268398
- 1316092
- 9681356
- 3012421607
- 2023950
- 3015332784
- 3003969055
- 3004082121
- 3030644259
- 3006979803
- 3007353764
- 3022516928
- 9680845
- 8020994
- 3003829571
- 3004425647
- 3009960170
- 3049552730
- 3009219448
- 2515379
- 3012502601
- 3014150341
- 3008729549
- 3013584861
- 3005558160
- 9612300
- 3002808270
- 3043355002
- 3002807120
- 3024787345
- 3003169405
- 3038718579
- 1035907
- 3008320092
- 3011554142
- 3015136927
- 3029952416
- 2918719
- 3044150131
- 3005728058
- 3011649314
- 3011707926
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 |
| 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 |
| K770941 | APPLIC SYSTEM ACTIVATOR, ESPE | Espe GmbH (Us) | 1977-06-02 |