510(k) K973248
- Device
- IMTEC BONE COLLECTOR SYSTEM
- Applicant
- IMTEC CORP.
- 510(k) number
- K973248
- Product code
- EHZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-19
- Date received
- 1997-08-29
- Regulation
- 872.6640
- Classification name
- Evacuator, Oral Cavity
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- M.K. PATTERSON
- Address
- 2401 N. Commerce P.O. Boxc 1562 Ardmore OK US 73402 73402
FDA Registration Numbers#
- 3007255375
- 3038718579
- 3004425647
- 3004605493
- 3017751928
- 2523320
- 8030905
- 2024980
- 1000179416
- 1915484
- 3011210208
- 3017910185
- 3004099493
- 8040278
- 3009384933
- 9611827
- 3003963832
- 3008729549
- 3004096429
- 3009219448
- 3010162973
- 3004193466
- 3015259866
- 3015173212
- 3035858919
- 3025414363
- 3015136927
- 3004201548
- 3004519921
- 3031582434
- 3015432501
- 1651260
- 2437780
- 3006008984
- 3002808270
- 3010598169
- 3004538333
- 3013584824
- 3003120666
- 3033011342
- 3008346537
- 3008559238
- 3007515069
- 3026326493
- 3004096300
- 1219113
- 9616872
- 3006979803
- 1836161
- 3003610374
- 8020659
- 3005554774
- 3000892153
- 3012421607
- 2424472
- 1422507
- 3011526299
- 3015146495
- 3003618527
- 2086043
- 3015703934
- 9611503
- 3024088964
- 3003418325
- 3010147274
- 1718912
- 9611367
- 1921846
- 3006210673
- 3004992978
- 2435946
- 1051614
- 3011169597
- 3027234828
- 3009420946
- 3003902312
- 2133714
- 3017498782
- 1941138
Source Documents#
Other 510(k) Records For Product Code EHZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941164 | TAP EXPRESS EJECTOR | Tap Express, Inc. | 1994-05-18 |
| K911072 | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | A & F Products | 1991-05-15 |
| K903718 | OROSCOPE MODEL NUMBER COS-100 | Cygnus Instruments, Inc. | 1990-11-09 |
| K892882 | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. | 1989-06-23 |
| K892881 | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. | 1989-06-23 |
| K880754 | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. | 1988-05-12 |
| K873545 | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT | Commercial Products & Engineering Co. | 1987-11-20 |
| K874401 | TITANIUM SUCTION TIP | Implant Innovations International, Inc. | 1987-11-12 |
| K864621 | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. | 1987-02-13 |
| K863769 | EVACUATOR TIPS | The Medical Group, Inc. | 1986-10-30 |
| K801682 | SPACELINE HIGH VOLUME EVACUATION HANDPIE | Pacific Dental Corp. | 1980-08-04 |
| K782068 | MVS UNIT, MODEL SEU-8 AND DEU-8, 80 | Dentsply Intl. | 1979-01-26 |
| K781488 | MVS-MODEL SEU-6, DEU-6 | Dentsply Intl. | 1978-09-27 |
| K781486 | STERI-VAC POWER UNITS | Cpac, Inc. | 1978-09-27 |
| K780701 | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. | 1978-05-16 |
Legacy Summary#
summary
FDA Review#
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