510(k) K854795
- Device
- HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
- Applicant
- FRAN HAZELTON CO.
- 510(k) number
- K854795
- Product code
- EIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-04
- Date received
- 1985-12-02
- Regulation
- 872.4565
- Classification name
- Remover, Crown
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANCES M HAZELTON
- Address
- 919 First St. Orland CA US 95963 95963
FDA Registration Numbers#
- 3014334038
- 8041151
- 3012421607
- 3021666757
- 9680244
- 3009049852
- 3009703496
- 3008902714
- 3003905396
- 3003882399
- 3012101664
- 8010159
- 9616246
- 9611062
- 3031564283
- 3015397788
- 3006059835
- 2431166
- 2521453
- 3011371465
- 3011625373
- 3005049358
- 3005067367
- 3005897698
- 3002769835
- 3027555943
- 1066741
- 2916714
- 3043047788
- 3002834291
- 3003969055
- 3011276344
- 2246990
- 3017352116
- 3002090132
- 9611112
- 3007751820
- 3003963832
- 2241860
- 8010665
- 8020776
- 3002769844
- 3003882387
- 3015156396
- 9680002
- 3031191035
- 3003407244
- 3029082594
- 3012226300
- 3013946322
- 8040881
- 9681540
- 3011215096
- 3010442693
- 3005621335
- 9611283
- 3011499367
- 9614075
- 3003877407
- 3015422158
- 3027556548
- 2429849
- 2511556
- 9680026
- 3016965929
- 8043992
- 3043355002
- 3009171220
- 9611367
- 1422507
- 1419489
- 3003700106
- 3001146947
- 3015272949
- 3039414397
- 3045853999
- 3013508670
- 8010732
- 3003244954
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992649 | ATD AUTOMATIC BRIDGE REMOVER | J. Morita USA, Inc. | 1999-10-29 |
| K951299 | EASY PNEUMATIC CROWN AND BRIDGE REMOVER | Dentco, Inc. | 1995-08-29 |
| K863500 | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | Pacific Union Dental, Inc. | 1986-09-22 |
| K842026 | H-TYPE BRIDGE REMOVER | Higa Manufacturing , Ltd. | 1984-07-11 |
| K833287 | SATIN CAST ECONOCAST | Genesis Industries, Inc. | 1984-01-03 |
| K833290 | C & B 40 PENTRO C & B40 | Genesis Industries, Inc. | 1984-01-03 |
| K833278 | C & B 45 | Genesis Industries, Inc. | 1983-12-29 |
| K833289 | C & B 61 PENTRON C & B61 | Genesis Industries, Inc. | 1983-12-29 |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Jeneric Ind. | 1983-12-29 |
| K833280 | SUPRA AP CHOICE 83 | Genesis Industries, Inc. | 1983-12-26 |
| K833285 | RX IV PENTRON IV | Genesis Industries, Inc. | 1983-12-22 |
| K833288 | C & B57 PENTRON C & B57 | Genesis Industries, Inc. | 1983-12-20 |
| K833279 | NATURELLE-LITE | Genesis Industries, Inc. | 1983-11-28 |
| K833281 | RX D PENTRON | Genesis Industries, Inc. | 1983-11-28 |
| K833282 | RX NYSP PENTRON 60 | Genesis Industries, Inc. | 1983-11-28 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases