510(k) K924351
- Device
- GLENROE ELASTIBITE STIMULATOR
- Applicant
- GLENROE TECHNOLOGIES
- 510(k) number
- K924351
- Product code
- KMY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-06
- Date received
- 1992-08-28
- Regulation
- 872.5525
- Classification name
- Positioner, Tooth, Preformed
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN F BOZMAN
- Address
- 1912 44th Ave. E Bradenton FL US 34203 34203
FDA Registration Numbers#
- 3026326493
- 3011649314
- 3005537733
- 1054986
- 3013641573
- 3021741991
- 8030452
- 1316408
- 3027303702
- 3003092374
- 3005515228
- 3044150131
- 3022296393
- 3015216243
- 3034686762
- 3009703496
- 3015169722
- 3014425175
- 3031799
- 3007130440
- 3031582434
- 3038718579
- 3009171220
- 3017352116
- 3017542591
- 3024749697
- 3010279788
- 3021381014
- 3003496134
- 3014289665
- 3015060216
- 1000486347
- 3010245461
- 3009440973
- 2126683
- 3010002722
- 3011258423
- 3005897698
- 3004095674
- 1000118628
- 1036212
- 3014701704
- 3013946322
- 3017450159
- 3012389497
- 8010908
- 3038209294
- 3016237718
- 3014683120
- 3013551048
- 3017619720
- 3010032042
- 8040278
- 3015674635
- 3008882689
- 3039359767
- 1836161
- 2411056
- 3015491441
- 1649995
- 3016455588
- 3015813269
- 2184045
- 8043622
- 3006707038
- 3005505603
- 2280629
- 3014054179
- 3022315836
- 3005598536
- 3013343038
- 3017138012
- 9615291
- 3009482106
- 9710005
- 2523320
- 3043149181
- 3007177751
- 1833132
- 3008261720
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KMY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931615 | NITE-GUIDE | ORTHO-TAIN, Inc. | 1995-04-14 |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | 1995-02-13 |
| K925064 | RELAX-O-GUARD | Aquatemp Service Co., Inc. | 1993-09-13 |
| K924975 | THE ORTHOTRAINER | Myofunctional Research Corp. Pty. , Ltd. | 1993-07-08 |
| K924974 | THE TMJ APPLIANCE | Myofunctional Research Corp. Pty. , Ltd. | 1993-06-23 |
| K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics | 1990-11-09 |
| K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | American Orthodontics | 1989-03-31 |
| K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin | 1984-01-10 |
| K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman | 1983-08-12 |
| K821458 | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. | 1982-06-09 |
| K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | 1978-06-28 |
Legacy Summary#
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FDA Review#
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