510(k) K781605
- Device
- R&r Absorbent Points
- Applicant
- RANSOM AND RANDOLPH
- 510(k) number
- K781605
- Product code
- EKN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-10-10
- Date received
- 1978-09-18
- Regulation
- 872.3830
- Classification name
- Point, Paper, Endodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3027344570
- 3038718579
- 2245654
- 3005176727
- 3036269993
- 2081055
- 3017910185
- 2511556
- 3012996495
- 8010468
- 3015136927
- 9681748
- 9615399
- 3015060193
- 3015461866
- 3031582434
- 2436986
- 9681750
- 3003637055
- 8040288
- 3012312751
- 3015526995
- 3010598169
- 8010629
- 3019741877
- 3031191035
- 9616517
- 3011824442
- 3005914490
- 3014326245
- 3030015903
- 3012477813
- 3009431661
- 3008249935
- 3012421607
- 3021388085
- 2086043
- 3024088964
- 8010414
- 3042866301
- 3006444232
- 3011215096
- 2024312
- 2183301
- 3009420946
- 3002807112
- 3014683120
- 8020994
- 3004580125
- 9616142
- 3021023132
- 3015977959
- 1032227
- 3015272949
- 3009171220
- 3015060216
- 3011434305
- 3017941947
- 2320721
- 3008887731
- 3025436467
- 3000303964
- 3006113314
- 3006550196
- 3043648115
- 3021284315
- 3010864832
- 3013538161
- 8031010
- 3008370577
- 3011554142
- 9681254
- 3014159752
- 9616128
- 3006186796
- 3004133229
- 3006017180
- 3030378557
- 3009756327
- 3012627824
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843017 | ABSORBENT ENDODONTIC POINT | United Dental Mfg., Inc. | 1985-01-09 |
| K821625 | ENDODONTIC PAPERPOINTS | Roeko | 1982-06-14 |
| K812886 | ENDODONTIC PAPER POINTS | United Dental Mfg., Inc. | 1981-11-16 |
| K800827 | PREMIER ABSORBENT POINTS | Premier Dental Products Co. | 1980-04-29 |
| K761203 | ABSORBENT POINTS | Johnson & Johnson Professionals, Inc. | 1976-12-13 |
| K760983 | ENDODONTIC INSTRUMENTS | Adp Intl., Inc. | 1976-11-15 |