510(k) K770598
- Device
- ENDODONTIC INSTRUMENTS, R&R CUTWELL
- Applicant
- Ransom and Randolph
- 510(k) number
- K770598
- Product code
- EKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-05
- Date received
- 1977-03-29
- Regulation
- 872.4565
- Classification name
- Reamer, Pulp Canal, Endodontic
- 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#
- 3007791573
- 3011554142
- 8020994
- 1032227
- 8043792
- 8030938
- 3010656982
- 3008370577
- 1054713
- 3003418325
- 1836161
- 3009219448
- 9610612
- 1525838
- 3009171220
- 1219518
- 3014334038
- 8030637
- 3006174295
- 3015276580
- 3013538161
- 3012501675
- 3042866301
- 8031010
- 3010160527
- 8040278
- 9611458
- 2320721
- 8010468
- 3038718579
- 3010145273
- 9611611
- 3006621310
- 2433629
- 3002692886
- 9680913
- 8031011
- 9611053
- 3008249935
- 3005972890
- 3006186796
- 8030607
- 3012101632
- 2183301
- 2515379
- 8023007
- 8030962
- 3019567808
- 3012477813
- 3012421607
- 8044177
- 1000286794
- 3004569445
- 2024312
- 3001644167
- 3002808270
- 8030343
- 3027344570
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823686 | REAMER TYPE K ENDODONTIC | United Dental Mfg., Inc. | 1982-12-28 |
| K822620 | ROOT CANAL REAMERS, TYPE K | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 |
| K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Ipco Corp. | 1980-02-19 |
| K770331 | DIALYSIS, JET SYSTEM | Janneck Ent. of Texas | 1977-04-20 |
| K770367 | ROOT CANAL FILES & REAMERS | Cemco Tool Co., Inc. | 1977-03-01 |