THERMAPREP PLUS OVEN
FDA 510(k) clearance K970134 · decided 1997-03-21
Clearance details
- K-number
- K970134
- Device name
- THERMAPREP PLUS OVEN
- Applicant
- Tulsa Dental Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-15
- Decision date
- 1997-03-21
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- EKM
- Device class
- 1
- Regulation number
- 872.3850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tulsa, OK, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EI DOWNPAK BARRIER SLEEVES (K073369) | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 |
| DOWN PAK (K070246) | Endo Twinn B.V. | 2007-02-16 |
| TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (K051573) | Dr. Howard Martin, P.A. | 2006-06-26 |
| ENDO TWINN (K042870) | Endo Twinn B.V. | 2005-01-11 |
| FIBERFILL SGP (K023819) | Pentron Clinical Technologies | 2003-03-26 |
| ANTIBACTERIAL GUTTA PERCHA (K971641) | Dr. Howard Martin, P.A. | 1997-07-21 |
| INJECT-R FILL (K931742) | Union Broach, Div. Moyco Industries, Inc. | 1993-05-27 |
| MICRODOSE RC-EZ (K924825) | Unicep | 1993-03-05 |
| TOUCH 'N HEAT MODEL 5002, MODIFICATION (K915243) | Analytic Technology | 1992-01-21 |
| THERMAPREP (K910224) | Tulsa Dental Products, Ltd. | 1991-03-29 |
| THERMAFIL ENDODONTIC OBTURATOR (K900986) | Tulsa Dental Products, Ltd. | 1990-11-13 |
| ENDO-PREP (K896663) | Pulpdent Corp. | 1990-02-14 |
Recalls involving this device
No recalls on record reference this clearance.