510(k) K780211
- Device
- 4-IN-1 DISP. CROWN & BRIDGE TRAY
- Applicant
- KERR CORPORATION (DANBURY)
- 510(k) number
- K780211
- Product code
- EHY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-02-16
- Date received
- 1978-02-08
- Regulation
- 872.6880
- Classification name
- Tray, Impression, Preformed
- 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#
- 1064583
- 2431166
- 2133714
- 3032747418
- 3013600135
- 3006608997
- 3005621335
- 3011164188
- 1836161
- 3017248108
- 3015259864
- 9681622
- 3004623350
- 3031564283
- 3005181866
- 3009893622
- 3023443842
- 3008902714
- 3015143007
- 1424785
- 3010583458
- 3010598169
- 3012477813
- 3009171220
- 3015276580
- 3003600526
- 3029507159
- 3015532217
- 3008763803
- 2521453
- 3006847937
- 3014610038
- 3010364969
- 9680002
- 3010455030
- 3015527834
- 3030644259
- 3043105508
- 1043617
- 3017575849
- 3012101664
- 3005665377
- 3045855232
- 3002769835
- 3013443455
- 2437780
- 8021050
- 9611385
- 3005735859
- 3015491448
- 3009170227
- 9614573
- 2511556
- 2429849
- 8043962
- 3009420946
- 3008582406
- 3007126709
- 2018957
- 3031799
- 3009268271
- 3012138716
- 3005343849
- 3010701675
- 3011707926
- 3030795695
- 3043009869
- 2436986
- 3011600579
- 2953749
- 3004598675
- 3015136927
- 3024088964
- 3006059835
- 3008922120
- 3030507585
- 3015527825
- 3004784004
- 2024980
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EHY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942668 | O-TRAY IMPRESSION TRAYS | Dentauraum, Inc. | 1994-07-22 |
| K896470 | EOS IMPRESSION TRAYS | Ivoclar North America, Inc. | 1990-02-09 |
| K884316 | OCCLUSAL HARMONY IMPRESSION TRAY | Advantage Dental Co. | 1988-12-22 |
| K863836 | POST TRAY | Market Masters, Inc. | 1986-10-14 |
| K850776 | PREFORMED DENTAL IMPRESSION TRAYS | L.A.K. Ent., Inc. | 1985-03-18 |
| K842273 | CROWN INDEX TRAY | Di-Equi Dental Products | 1984-07-31 |
| K842274 | F-G-P TRAY | Di-Equi Dental Products | 1984-07-31 |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Buffalo Dental Mfg. Co., Inc. | 1984-07-13 |
| K841323 | FUZZY TRAY | Buffalo Dental Mfg. Co., Inc. | 1984-06-27 |
| K833485 | IMPRESSION TUBE ADJUSTABLE | Zefr, Inc. | 1983-12-26 |
| K810524 | SR-IVOTRAY SPECIAL | J. Aderer, Inc. | 1981-03-17 |
| K810525 | SR-IVOTRAY UNIVERSAL | J. Aderer, Inc. | 1981-03-17 |
| K801548 | PERF-LOCK IMPRESSION TRAY | Dentsply Intl. | 1980-07-21 |
| K800900 | PREMIER TRIPLE TRAY | Premier Dental Products Co. | 1980-04-29 |
| K780678 | IMPRESSION TRAY | Rocky Mountain Orthodontics, Inc. | 1978-04-28 |
Legacy Summary#
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FDA Review#
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