510(k) K872943
- Device
- Disposable Articulator
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K872943
- Product code
- EJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-11
- Date received
- 1987-07-28
- Regulation
- 872.3150
- Classification name
- Articulators
- 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#
- 4565
- 9614733
- 3004425647
- 2523320
- 2431166
- 8030870
- 3005942449
- 3005176727
- 3006059835
- 3009703496
- 3004892425
- 3013526557
- 2511556
- 8040278
- 3012101664
- 3002090132
- 9615291
- 2411797
- 3004598675
- 3004095674
- 3015136927
- 3001685118
- 3002808149
- 2436986
- 3004629313
- 3009340886
- 3015895045
- 3012925629
- 3008808049
- 3015131021
- 3001297506
- 3027556548
- 1032347
- 3002675176
- 3001620590
- 3011649314
- 9616704
- 3009142030
- 2435118
- 1836161
- 3029082594
- 3012477813
- 3003637274
- 2031961
- 2424472
- 3005092287
- 1000493628
- 9680244
- 3030515618
- 3014732
- 9616103
- 3003481336
- 3009646999
- 1219645
- 3011164188
- 3011511773
- 3011625373
- 2087259
- 2183301
- 9616978
- 9612352
- 1043617
- 3014683120
- 2087470
- 3005897698
- 3019404837
- 3011499367
- 9681622
- 3003334541
- 3004966444
- 3021023132
- 3003882387
- 3009171220
- 3016170492
- 3015512299
- 1000277456
- 3009496224
- 3002769835
- 9614069
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926190 | ALRAND INC. (DENTAL HAND INSTRUMENTS) | Alrand, Inc. | 1994-01-18 |
| K896131 | GNATHOMAT ARTICULATOR | Ivoclar North America, Inc. | 1989-12-04 |
| K892373 | DENTAL PLASTIC BITE FORK | Texapol Corp. | 1989-06-12 |
| K884418 | PREMIER DIE-TRAK ARTICULATOR | Premier Medical | 1988-11-14 |
| K863009 | GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX | Sds Dental, Inc. | 1986-09-25 |
| K854702 | PLASTIC MOUNTING RINGS | Almore Intl., Inc. | 1986-03-06 |
| K833039 | HANDY IIM | Shofu Dental Corp. | 1983-10-04 |
| K811075 | BALANCE ARTICULATOR | Almore Intl., Inc. | 1981-05-13 |
| K810971 | THE GNATOMET | Bauer, Cheng & Associates, Inc. | 1981-05-05 |
| K801342 | DISPOSABLE ARTICULATOR | Williams Gold Refining Co., Inc. | 1980-07-08 |