510(k) K110759
- Device
- TEMPOCEM
- Applicant
- DMG USA, INC.
- 510(k) number
- K110759
- Product code
- EMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-10
- Date received
- 2011-03-18
- Regulation
- 872.3275
- Classification name
- Zinc Oxide Eugenol
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA PAPINEAU
- Address
- 5 Whitcomb Ave. Ayer MA US 01432 01432
FDA Registration Numbers#
- 3011689956
- 3038718579
- 3027315856
- 3010245461
- 3012187973
- 1719513
- 3015414875
- 2523320
- 1215305
- 3012101632
- 2024312
- 3018507299
- 3027283275
- 9680845
- 3005176727
- 3013584861
- 2022039
- 8044038
- 2183301
- 8044164
- 3004727093
- 3016447764
- 2081055
- 3010864832
- 1836161
- 3015542306
- 3006805063
- 3008912871
- 3043226252
- 3010131268
- 3012996495
- 5243
- 8020994
- 3011545201
- 3012477813
- 3011545197
- 1937100
- 1413475
- 3006789197
- 3021023132
- 9616128
- 3005628474
- 3002911411
- 3012421607
- 3011944170
- 3032312561
- 8010908
- 3001644167
- 3008822460
- 9615399
- 3036999986
- 3009171220
- 3004149679
- 3015548849
- 2086043
- 8030607
- 1424442
- 3006644229
- 3003418325
- 8010414
- 2437780
- 2515379
- 3040335058
- 8021851
- 2938386
- 8030067
- 3007353764
- 3010583458
- 3017248108
- 3015128224
- 1721647
Source Documents#
Other 510(k) Records For Product Code EMB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161630 | Provicol QM Plus | Voco GmbH | 2016-09-15 |
| K120695 | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | Dentist IN A Box Pty., Ltd. | 2012-06-12 |
| K073539 | PROVISA CEM | Cavex Holland BV | 2008-01-31 |
| K020158 | NON-EUGENOL TEMPORARY CEMENT | J. Morita USA, Inc. | 2002-03-07 |
| K941066 | DENTAL 911 | L.A.F. Industries, Inc. | 1995-05-24 |
| K861681 | DENTIMEDIC DENTAL EMERGENCY KIT | Dentimedic | 1986-09-23 |
| K862745 | EUGENOL USP | E&D Dental Manufacturing Co. | 1986-07-31 |
| K821581 | DEN TEMP | Majestic Drug Co., Inc. | 1982-06-14 |
| K801779 | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | Oxy Dental Products, Inc. | 1980-08-07 |
| K772315 | KWIKAP | Den-Mat Corp. | 1978-01-03 |
Legacy Summary#
summary
FDA Review#
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